Category Archives: NICE

Ipsen receives European first-line approval for Cabometyx

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Ipsen has revealed that it has received approval for the use of Cabometyx for first-line use in patients with advanced renal cell carcinoma (RCC).

The approval builds on the second line approval it had previously received in 2016, although negotiations with numerous European countries over the price of medicine have delayed access for many nations until recently.

NICE gave approval for the use of the treatment in July 2017, close to a year after its EC approval.

Though sales so far have not been blistering, recording European sales of only £25 million in the first quarter, it is expected that this first-line approval and with numerous funding agreements falling into place with payers that the drug sales will grow quickly.

Part of the reason for this is the advantage it holds over a main competitor, in BMS’ Opdivo; Cabometyx is differentiated by being available in oral form, which makes it far more convenient than having to visit a hospital for IV infusion.

“Today’s EC approval is a step forward for advanced kidney cancer patients in Europe who will be able to access a new oral first-line treatment option that offers significant improvement over the standard of care”, said Harout Semerjian, Executive Vice President, Chief Commercial Officer, Ipsen.  “Ipsen remains committed to improving patients’ lives by continuing to develop new therapies and expanding the potential of Cabometyx across different indications.”

The approval is based on results from a Phase 3 trial that hit primary endpoint of extending progression-free survival (PFS). The data revealed that PFS was improved by 8.6 months, compared with 5.3 months of patients taking Pfizer’s Sutent. In terms of overall survival (OS), the company reported that it showed a favourable, though not statistically significant, trend – as OS with Cabometyx stood at 26.6 months against 21.2 months on Sutent.

In terms of further development, Ipsen is developing the treatment as an adjunct alongside immunotherapy.

SOURCE: www.pharmafile.com/news/517387

SMC approves licence for liver cancer treatment

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Stivarga® (regorafenib) has been accepted by the Scottish Medicines Consortium (SMC) as a monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar® (sorafenib).1

Regorafenib is the first medicine to be specifically licensed for second-line use in patients with HCC who had formerly been treated with sorafenib, the German multinational pharmaceutical company Bayer has announced.

The medicine is taken orally and works by slowing down the growth and spread of cancer cells by cutting off the blood supply that keeps cancer cells growing.2

Judi Rhys, chief executive of the British Liver Trustsaid: “A diagnosis of hepatocellular carcinoma (HCC) is truly devastating – it is a horrendous type of liver cancer that is often diagnosed very late with few treatment options.

“We are delighted that the Scottish Medicines Consortium (SMC) has accepted the Trust’s evidence on behalf of patients and agreed to the use of this drug for patients in Scotland.

Evidence shows that outcomes for people with advanced liver cancer are particularly poor, so this is an important step.”

She added the decision “highlights a two tier system where patients in other parts of the UK are denied access to this new treatment that can improve outcomes”.

The positive SMC announcement follows the recent decision from the National Institute for Health and Care Excellence (NICE) to not recommend the use of regorafenib on the NHS in England.3

Amanda Cunnington, head of patient access, Bayer UK said regorafenib was “the first advancement in licensed treatment for liver cancer patients in nearly a decade”and that it offers “the first and only approved second-line systemic treatment option which could significantly improve patients’ overall survival”.

Regorafenib is licensed based on data from the international, multicentre, placebo controlled Phase III RESORCE [Regorafenib after Sorafenib in patients with hepatocellular carcinoma; NCT 01774344] trial. The trial investigated patients with HCC whose disease had progressed during treatment with sorafenib.4

In the trial, regorafenib plus best supportive care (BSC) was shown to provide a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo plus BSC (10.6 vs. 7.8 months, respectively, (HR 0.62; 95% CI 0.50-0.79; p=0.000017)) which translates to a 37% reduction in the risk of death over the trial period.4

Adverse events observed in the RESORCE trial were generally consistent with the known safety profile of regorafenib.4 The most common (>=30%) treatment-emergent adverse events were hand–foot skin reaction, diarrhoea, fatigue and hypertension.4

HCC is the most common type of primary liver cancer.5 Liver cancer is a difficult-to-treat cancer with an annual mortality rate of 48,000 in the EU.6 Globally, it is the second leading cause of cancer-related deaths.6In the UK, there are over 5500 new cases of primary liver cancer diagnosed each year, which is around 15 patients each day.7

References

  1. SMC. regorafenib 40mg film-coated tablets (Stivarga®). SMC No 1316/18. Bayer plc. April 2018. Available at: http://www.scottishmedicines.org.uk/files/advice/regorafenib__Stivarga__FINAL_March_2015Revised_250315_for_website.pdf (Last accessed May 2018).
  2. European Medicines Consortium (EMC) Stivarga® Patient Leaflet. Available at: https://www.medicines.org.uk/emc/files/pil.1263.pdf (Last accessed April 2018).
  3. National Institute for Health and Care Excellence (NICE) Regorafenib for previously treated advanced hepatocellular carcinoma. Technology appraisal guidance [TA514] Published date: 21 March 2018.  Available at: https://www.nice.org.uk/guidance/ta514/chapter/1-Recommendations  (Last accessed April 2018).
  4. Stivarga® (regorafenib) Summary of product characteristics. Bayer HealthCare. September 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Info… (Last accessed April 2018).
  5. Cancer Research UK. Liver Cancer Types. Available at: http://www.cancerresearchuk.org/aboutcancer/liver-cancer/types. (Last accessed April 2018).
  6. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012.http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx (Last accessed April 2018).
  7. Cancer Research UK. Liver Cancer Incidence Statistics. Available at http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/livercancer/incidence#heading-Zero  (Last accessed April 2018).

SOURCE: www.hospitalpharmacyeurope.com/editors-pick

Vertex says ‘some way’ to CF drug price deal after NHS meeting

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Representatives of Vertex Pharmaceuticals and NHS England met last week in an attempt to end a two-year long stand-off over the price of cystic fibrosis drugs – but there is still a long way to go before the matter is resolved.

Pressure from patient groups forced a parliamentary debate on access to Vertex’s CF drugs, after NICE rejected the company’s Orkambi combination therapy in 2016.

An online petition attracted more than 100,000 signatures, the threshold for a discussion in Parliament, and ministers have written to Vertex asking for the matter to be resolved.

Vertex is asking the NHS for a deal covering the price of its portfolio of CF drugs, including those that are yet to be approved, and will expand the proportion of the disease population who will be eligible for treatment.

The company confirmed in a statement that Vertex met with representatives of NHS England last Wednesday.

But a spokesperson added: “Both parties recognise there is still some way to go to reach an agreement and Vertex is committed to working together to achieve this. We share the cystic fibrosis community’s sense of urgency and have agreed to meet again in the coming weeks. There’s lots of work to do on both sides ahead of this to progress discussions as quickly as possible.”

However there is hope that there will be further progress in meetings over the coming weeks.

pharmaphorum understands that the biggest stumbling block is that NHS England wants to pay the same price as Vertex’s already-approved and NICE-backed Kalydeco (ivacaftor) for the company’s drugs.

Kalydeco’s list price is around £182,600 per year, although the company has agreed a confidential discount.

Cystic Fibrosis Trust public affairs manager Lynsey Beswick said: “We welcome the news that Vertex and NHS England have had further talks on the company’s medicines. This appears to be positive progress in our goal to gain access to the most advanced new medicines for people with cystic fibrosis at the earliest possible opportunity.”

SOURCE: www.pharmaphorum.com/news

Final NHS nod for Roche’s RoActemra

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Roche/Chugai’s RoActemra should be routinely offered throughout the NHS to adults with giant cell arteritis (GCA) within the next three months, following a final green light from cost regulators.

Almost 15,000 patients develop GCA in the UK every year. The condition is a potentially life-threatening form of vasculitis that results in inflammation of blood vessels, which can be difficult to diagnose because of its wide range of symptoms, including severe headaches, scalp tenderness and jaw pain. If left untreated it can lead to blindness, aortic aneurysm or stroke.

To date, management of GCA has been limited to long-term high-dose steroids, but this can cause skin problems and weight gain, as well as diabetes and osteoporosis in the long-term. There have been no treatment advances for GCA for nearly 60 years.

RoActemra (tocilizumab) is an anti-IL-6 receptor licensed for the treatment of adult patients with moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in children two years of age and older, and for the treatment of GCA in adults.

Clinical trial results show that after having RoActemra plus a tapering course of glucocorticoids for one year, more people stay in remission and need lower doses of glucocorticoids compared with people having glucocorticoids alone.

The National Institute for Health and Care Excellence is recommending funding for one year’s treatment with the drug for patients who suffer flares of their GCA or may not respond fully to steroids, as their disease is most difficult to control.

SOURCE: www.pharmatimes.com/news

Row over CF drug funding as NHS rejects Vertex offer

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A deal covering new cystic fibrosis drugs is unlikely to happen unless the manufacturer Vertex agrees to drop its prices, NHS England has indicated.

Vertex is seeking a deal to fund national access in England to its cystic fibrosis (CF) drug, Orkambi (lumacaftor+ivacaftor),  a combination which extends the number of CF whose underlying disease can be treated.

Over the last 12 months NHS England has taken a lead role in negotiating directly with pharma companies, and has created a dedicated Commercial Medicines Unit for the task.  Faced with static NHS budgets and growing budget pressure, it is taking a harder line on prices, but also says it is willing to negotiate deals based on outcomes.

However no such deal has been struck on this occasion. In fact CF campaigners have reacted angrily to this NHS England rejection, and Vertex is critical of how the budget holder has conducted the discussion, saying NHS England has only communicated via email.

MPs are set to debate availability of cystic fibrosis drugs in Parliament later today, after a petition calling for them to be funded by the NHS attracted more than the 100,00 signatures.

But for now NHS England has said it is not interested in a deal covering cystic fibrosis drugs, despite the growing pressure from campaigners.

Vertex is keen to get its CF drugs funded in England and the wider UK because of the high number of patients with the disease here.

With 10,000 patients affected, the UK has the second highest number of CF patients in the world and as such would be an important and valuable market for Vertex.

The manufacturer is seeking a deal that would cover Orkambi and any other future CF drugs that it develops as part of a “portfolio approach”.

This was sparked by NICE’s decision to reject Orkambi in 2016, which was too expensive for NICE despite discounts and greater flexibility in funding for rare disease drugs.

Although the negotiations over pricing are confidential, campaigners united under the hashtag #ukneedsorkambi are speculating that NHS England wants Vertex to expand the number of patients receiving treatment from 400, to almost 4,000 but without receiving any extra funding.

Pharmaphorum quizzed NHS England on the details of the negotiations, and a spokesperson responded with a short statement.

The spokesperson said: “The NHS can only offer treatments which are both effective for patients and offer good value for taxpayers, so it’s crucial that drugs companies work with the NHS to get a positive outcome.”

“Following advice from NICE, the NHS has asked this particular drug company to review its proposed pricing, and unless this happens further progress at this time is frankly unlikely.”

A Vertex spokesperson said the company is “astonished and dismayed” with NHS England’s response.

“It amounts to a refusal to make any additional funding available for Orkambi or future medicines,” a company spokesperson said.

“Cystic fibrosis (CF) is a devastating disease where half of people die by the time they are age 31. The situation with CF in the UK is unique and needs a unique solution – this is what our portfolio approach that we proposed in February offers.”

“Negotiations over email are rarely productive and CF patients do not have time to waste. We call on all parties to come to the table to engage in meaningful dialogue about a way forward – on behalf of CF patients.”

SOURCE: www.pharmaphorum.com/market-access-2

NICE ‘considering’ evidence to cut treatment threshold for hypertension

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NICE is considering new evidence which led to drastically lowered hypertension thresholds in the US.

The clinical advisory body, which is currently reviewing UK hypertension guidelines with a view to updating them in August 2019, told Pulse the reviews were ‘asking the same questions’.

The new US guidelines, published by the American Heart Association, decreased the threshold for stage one hypertension from an average systolic blood pressure of 140 to 130 mmHg, and from ≥160 to ≥140 mmHg for stage two.

Researchers said the changes could mean an extra 14% of people were diagnosed with hypertension, which would bring the total number to 46% of the country’s population.

The change was prompted by the 2015 SPRINT study, which showed that by treating patients with a target blood pressure of 120 mmHg, rather than the 140 mmHg target, mortality and cardiovascular events were significantly reduced.

When asked whether the changes brought in the US would be considered in the updated UK guidelines, a NICE spokesperson said: ‘Yes, we are asking some of the same questions being considered in the US and in doing so will be considering some of the same evidence.’

Current NICE guidelines define stage one hypertension as an average blood pressure of 135/85 mmHg or higher, and stage two as 150/95 mmHg or higher. It states that doctors should ‘offer antihypertensive drug treatment to people of any age with stage two hypertension’.

If the UK were to follow the US example, many patients currently defined as having stage one and treated with lifestyle changes could be pushed into stage two and medicated.

But this comes as last year, a meta analysis of 24 studies found that the evidence for reducing blood pressure targets to below 140 mmHg in over-60s was inconsistent.

The paper said that although lowering the targets could be beneficial, they could also be linked with a higher medication burden and an increased risk of short-term issues, such as hypotension.

Cardiology expert Dr Chris Aden, a GP in Southampton, said: ‘It’s going to be challenging in terms of the numbers they’re suggesting.

‘I think it’s down to good clinical common sense in how we apply it, particularly in the elderly or more frail groups’.

RCGP chair Professor Helen Stokes-Lampard said: ‘Lowering the threshold for making the diagnosis of any condition is a significant decision, that will affect thousands, if not millions of patients, and must not be taken lightly.’

‘One concern GPs already have is overdiagnosis – where we are giving a label to a situation thereby medicalising it, and prescribing medications when the benefits to the individual patient may be very limited.

‘This can be harmful for patients both in terms of causing unnecessary anxiety, and in terms of taking medication that they might not need.’

Pulse revealed in 2016 that new evidence including the SPRINT trial had prompted NICE advisors to consider updating hypertension guidelinesfor the first time since they were published in 2011.

Hypertension guidelines in full

New US classification

Normal <120/80 mmHg

Elevated 120-129/<80 mmHg

Stage 1 hypertension 130-139/80-89 mmHg

Stage 2 hypertension ≥140/90 mmHg

Current NICE guideline

Stage 1 hypertension – Clinic blood pressure is 140/90 mmHg or higher and subsequent ambulatory blood pressure monitoring (ABPM) daytime average or home blood pressure monitoring (HBPM) average blood pressure is 135/85 mmHg or higher

Stage 2 hypertension – Clinic blood pressure is 160/100 mmHg or higher and subsequent ABPM daytime average or HBPM average blood pressure is 150/95 mmHg or higher

Severe hypertension – Clinic systolic blood pressure is 180 mmHg or higher or clinic diastolic blood pressure is 110 mmHg or higher

SOURCE: www.pulsetoday.co.uk/news/clinical-news

Blood test could predict response to breast cancer drug early

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A new study has found that a blood test for cancer DNA could predict if a woman is responding to the new breast cancer drug palbociclib, months earlier than current tests.

Scientists from The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, say the test could detect in two to three weeks whether the drug is working, although they caution that the results need replicating before they are used clinically.

The research, published today in the journal Nature Communications, was largely funded by the Medical Research Council (MRC). The researchers tested women with oestrogen receptor positive breast cancer – the most common kind – who were taking part in a clinical trial of palbociclib for advanced breast cancer.

In November 2017, palbociclib was approved for use on the NHS by NICE for women with previously untreated advanced breast cancer.

Currently, women must wait two to three months to find out if palbociclib is working, via a scan.

The new blood test instead looks for circulating tumour DNA – fragments of DNA shed by the cancer that have entered the bloodstream. The DNA mutations associated with the cancer can be detected in these samples.

The researchers found that they could predict if the palbociclib treatment would work by comparing the amount of a gene PIK3CA detected in a blood test before treatment and 15 days after starting treatment. In the study, 73 women had the PIK3CA mutation and were given blood tests before and after starting palbociclib treatment.

In these women, the researchers found that those who had a small decrease in PIK3CA circulating DNA at 15 days had a median progression-free survival (the length of time the patient survived and the cancer did not get worse) of only 4.1 months, compared to women with a large decrease in PIK3CA, who had a median progression-free survival of 11.2 months.

The test could allow the women in the first group for whom the treatment is not as effective to be identified early, so that they could consider altering their treatment.

Professor Nicholas Turner, senior author and Professor of Molecular Oncology at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said: “Palbociclib is one of a new class of drugs that delays cancer progression for patients with advanced breast cancer, but it’s not effective for everybody. The problem is we have to wait for two to three months before doing a scan to see if the therapy is working.

“Our new study found that a blood test for cancer DNA in the first two weeks of treatment indicated whether the drug was likely to be effective. Having an early indication of how likely a treatment is to work might allow us to adapt treatment – switching some patients to an alternative drug that is more likely to benefit them.”

Dr Nathan Richardson, Head of Molecular and Cellular Medicine at the MRC, said: “This study provides early evidence that might help us understand sooner when a drug is successfully treating breast cancer, and if not, it can be discontinued and better approaches pursued.”

The research also received funding from the charity Breast Cancer Now and the pharmaceutical company Pfizer.

SOURCE: www.pharmafield.co.uk/Pf-Fox-News/General/2018/03

How can pharma navigate the complex marketing landscape?

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

The first chapter of pharma’s commercial evolution takes us from the insatiable sales-drive of the 1980s to the present, highly complex marketing landscape.

It is easy to forget that our competitive industry still has 80-90% gross margins and, as a consequence, its traditional commercial model is driven by sales growth, rather than worrying about costs.

Under most circumstances, incremental sales drive incremental profit. Within the affiliates this is obvious, and country managers have often resisted attempts by corporate counterparts to take a centralised approach to sales and marketing, claiming their country’s commercial ecosystem is unique and not amenable to meddling.

Of course, the modern pharma company will also have to conduct market access, medical education and phase IV studies within its affiliates, but the reality is that most affiliate activity is focused on sales. For large pharma companies the sales and marketing budget usually beats R&D budgets by 1.7 times, and this is becoming increasingly difficult to justify.

Rise of primary care dominance

Throughout the 1980s and 90s the focus on sales-driven growth led to the evolution of some very different ways of working within primary care, from co-promotion and co-marketing with embedded local players, to the ‘petal’ system of multiple salesforces detailing overlapping product ranges.

The purpose of these techniques, together with employment of contract sales teams, was a sort of ‘shock and awe’ strategy which swamped the physician with frequent visits about particular products. The competitive response was usually swift and commensurate, resulting in a commercial arms race between players within a hotly contested therapeutic area.

This was known as the ‘share of voice’ model, and when applied to large primary care categories, it drove top line growth so successfully that governments and institutional payers were forced to find a response to escalating drug bills around the world.

Backlash from health technology

This response varied from country to country, but has taken two main forms; the Health Technology Assessment response and the consolidated payer response. Throughout the 1990s and 2000s, in the UK (NICE), much of Europe, Australia and parts of Asia, there has been systematic developing of a process that assesses whether a product represents value for society.

Much of the health economics work is shared among countries, and pricing comparisons made between the same product in different countries are routine. The benchmarks for the monetary value of a healthy human being are the subject of debate, but are necessary to make budgetary choices in a system without unlimited resources.

The consolidated payer model, operating in the US through pharmacy benefit managers such as Express Scripts, relies on large payers exerting pressure on manufacturers for rebates, with some undifferentiated product portfolios having to rebate as much as 50% of their gross price.

The impact of health technology assessments can be seen today, manifesting itself in pricing pressure, therapeutic substitution, a diminution of decision-making by physicians and a conscious shift towards products with a confirmed medical need. A decline in R&D productivity, however, has not made this process easy.

Dead end: Primary care hits a wall

Many commentators blame the decline in R&D productivity for the steep fall in product approvals through the 2000s but, in reality, there have been several forces at work.

The rise in genomics, together with high-speed screening techniques, led to a belief that chemical libraries could be screened against unprecedented targets and that optimised drug candidates would flood through the discovery phase into phase I trials.

The sharp product rise in the early clinical phases then came to a shuddering halt during phase II ‘proof of concept’ studies, when large numbers of clinical failures unveiled the reality – there is no short cut to understanding disease biology.

As research cul de sacs were explored, a squeeze on primary care products began in the form of price pressure from above and greater safety demands from below. As a consequence, and aided by the rise in technology, a rapid increase in the proportion of newly-approved, biological in origin drugs commenced.

Monoclonal antibodies, vaccines, enzyme replacement therapy and other therapeutic peptides, aided by insatiable demand for insulin, developed strong sales and completely changed the nature of commercial interfacing with physicians.

Biologicals change the commercial dynamic

The pressure on primary care products, together with the impact of the patent cliff in 2012/13, have combined to drive sales of primary care products into stagnation. Much of industry downsizing, particularly within commercial operations, has been in response to this.

Perhaps most merger and acquisition activity within pharma also has its origins in this relentless pressure on primary care sales and the need to reload the pipeline quickly with biologicals and specialties.

The success of biologicals and other specialties, such as oral cancer drugs, in terms of both approval and sales, has required the industry to change its commercial emphasis. The huge traditional focus on primary care or family doctors has changed to specialists, and their support workers within a secondary care or hospital environment.

The increased complexity of the specialty sell, sometimes involving multiple decision-makers, formulary approval, health economic arguments, companion diagnostics and performance-related reimbursement, has required a much smaller, but more skilled group of people to interface with the healthcare network.

Many companies have yet to find the necessary mix of skills within their workforce and are still working under the old assumptions that spending on promotional activities can remain as high as it used to be under traditional models. They do so at their peril. Check out Part 2in the next issue, as promotional resources and modern data come under intense scrutiny.

SOURCE: www.pharmafield.co.uk/features

Eisai disappointed after NICE rejects earlier use for breast cancer drug

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Eisai has been dealt another disappointment from NICE, which says its breast cancer drug Halaven should not be regularly used on the NHS.

The company noted that the Halaven (eribulin) continues to be available for patients in third line – but more recently NICE had been assessing the drug after one chemotherapy regimen.

In the final guidance NICE said it was unclear whether a 4.6 month overall survival increase compared with capecitabine chemotherapy was down to treatments given after Halaven.

NICE noted that the drug did not increase progression free survival compared with chemotherapy, and that Halaven therapy is usually stopped once the disease progresses.

The uncertainty caused means that the cost per Quality Adjusted Life Year for Halaven in this use is around £69,800, according to NICE’s calculations.

This is too expensive for the NHS, even though NICE has extra leeway above its usual £30,000 threshold.

But Gary Hendler, Chief Commercial Officer Eisai Oncology Business Group, and chairman and CEO Eisai EMEA said he was “disappointed” after another knock-back from NICE.

Although NICE recommended funding for Eisai’s Lenvima (lenvatinib) in thyroid cancer last month, this was after a wait of more than two years primarily because of a change to the way NICE and the Cancer Drugs Fund are organised.

Halaven was also removed from the Cancer Drugs Fund under previous arrangements in 2015 because it was overspent. However this decision was eventually reversed and the drug was eventually rubber-stamped for regular NHS funding in late 2016.

Hendler said in a statement: “Eisai is yet again extremely disappointed with a decision from NICE. Metastatic breast cancer patients can only currently access a limited number of new treatments in England, and as eribulin has been shown to significantly improve overall survival in women with this disease it is an important option that they should have access to as early as possible.”

“Denying earlier access to it for these patients will affect their outcomes and as a company focused on making a positive difference to the lives of patients and their families, NICE’s decision concerns us greatly. Thankfully patients can still access eribulin in the third line.”

Eisai, which has built a multi-million pound manufacturing base in Hertfordshire, has threatened to stop investing in the UK because of difficulties getting drugs reimbursed.

This is despite pharma-friendly initiatives such as tax breaks on drugs that are developed and manufactured in the UK.

SOURCE: www.pharmaphorum.com/news

NICE bars NHS access to Lenvima, Nexavar for thyroid cancer

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NHS treatment cost regulators have published draft guidelines rejecting funding for Eisai’s Lenvima and Bayer’s Nexavar for treating certain patients with thyroid cancer.

The decision relates to advanced differentiated thyroid cancer that has spread to other parts of the body and cannot be operated on, in adults whose disease does not respond to radioactive iodine.

The committee heard that thyroid cancer is rare, and that the only option for patients unable to receive treatment with  Lenvima (lenvatinib) or Nexavar (sorafenib) is best supportive care.

In the draft guidelines, NICE notes that both drugs are effective in delaying disease progression compared to best supportive care, but says there is some uncertainty in establishing longer term survival.

The committee concluded that the incremental cost effectiveness ratios (ICERs) were “considerably higher” than what is normally considered to be cost effective to recommend for routine NHS use, but could not provide more specific details as the exact figures are commercially sensitive.

Also, as there are no ongoing clinical trials which might provide more evidence on overall survival benefit, the drugs could not be considered for inclusion in the Cancer Drugs Fund (CDF) either.

Approximately 3,400 people are diagnosed with thyroid cancer each year.

SOURCE: www.pharmatimes.com/news