Charity furious over SMC rejection of Novartis breast cancer drug

by Admin 13. October 2015 09:40

The Scottish Medicines Consortium has accepted six new therapies for routine use on the NHS Scotland but the rejection of Novartis’ Afinitor for breast cancer has led to criticism from charities.

The SMC said it was unable to recommend Afinitor (everolimus) because Novartis “did not present a sufficiently robust economic analysis" in its submission. This did not go down well with charities and Nicolas White, head of Scotland at Breast Cancer Care, said: "Yet again women in the country living with incurable secondary breast cancer “have been failed - everolimus is the fourth drug they have been denied in the past year”.

He added that “this devastating decision also creates a UK-wide postcode lottery, given the medicine is available in England and Wales, but not Scotland”. Mr White went on to say that “the new system is clearly not working for women with incurable breast cancer. Rather than just paying lip service to the views of patients, the SMC and Scottish Government urgently need to review this process - ensuring the patient voice is at the very heart of decision-making”.

However, the SMC had better news for men with incurable prostate cancer after it recommended Johnson & Johnson’s Zytiga (abiraterone) and Bayer’s Xofigo (radium-223). Roche’s Herceptin (trastuzumab), also got backing for use on the NHS for gastric cancer.

There were also recommendations for Boehringer Ingelheim’s Ofev (nintedanib) for idiopathic pulmonary fibrosis, and Santen’s Ikervis (ciclosporin), eye drops for the  treatment of severe keratitis in adults with dry eye disease. The SMC has also accepted Novo Nordisk’s type 2 diabetes combination therapy Xultophy (insulin degludec/liraglutide).

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UK is best place in the world to die

by Admin 8. October 2015 09:24

The UK’s end-of-life care is the best in the world, according to a report published by  the Economist Intelligence Unit report.

The 2015 Quality of Death Index measures palliative care in 80 countries around the world and the UK comes top, due to its comprehensive national policies, the extensive integration of palliative care into the National Health Service, “a strong hospice movement and deep community engagement on the issue.” The UK also came top in the first Quality of Death Index, produced in 2010.

In the report, commissioned by the Lien Foundation, a Singaporean philanthropic organisation, Australia and New Zealand take second and third place, as they did in 2010, while rich European and Asian countries dominate the top 20, along with the US in 9th and Canada in 11th. India and China rank 67th and 71st respectively.

The EIU noted that while many developing countries are still unable to provide basic pain management due to limitations in staff and basic infrastructure, some “demonstrate the power of innovation and individual initiative”. For example, Panama (31st) is building palliative care into its primary care services, while Mongolia (28th) has seen rapid growth in hospice facilities and teaching programmes; Uganda (35th) “has made huge advances in the availability of opioid painkillers”, the EIU concludes.

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MSD melanoma immunotherapy Keytruda gets NICE okay

by Admin 8. October 2015 09:12

Patients with advanced skin cancer will now be able to get access to Merck, Sharp & Dohme’s immunotherapy Keytruda on the National Health Service in England and Wales, after the National Institute for Health and Care Excellence issued final guidance backed its use.

The cost watchdog is recommending Keytruda (pembrolizumab) for some patients with advanced melanoma that is either unresectable or metastatic, but only if the disease has progressed following treatment with Bristol-Myers Squibb’s Yervoy (ipilimumab), or a BRAF or MEK inhibitor in BRAF V600 mutation-positive disease.

The recommendation also depends upon MSD providing the treatment to the NHS at the discount agreed in the confidential patient access scheme. NICE concluded that the most plausible incremental cost effectiveness ratio for the drug compared with best supportive care was likely to be less than £50,000 per quality-adjusted life year (QALY) gained.

Carole Longson, NICE Health Technology Evaluation Centre director, said there were over 13,000 people diagnosed with malignant melanoma in the UK in 2011, and it “accounts for more deaths than all other skin cancers combined. This will be welcome news to patients and healthcare professionals alike”.

Keytruda was the first drug to be approved through the UK government’s Early Access to Medicine Scheme, which aims to give patients with life-threatening or seriously debilitating conditions access to promising new treatments that have yet to receive official marketing approval.

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FDA approves Merck & Co, Gilead and Alkermes therapies

by Admin 6. October 2015 09:47

The US Food and Drug Administration has granted accelerated approval for Merck & Co’s immunotherapy Keytruda for advanced non-small cell lung cancer in patients whose disease has progressed after other treatments and with tumours that express the protein PD-L1.

The agency has backed Keytruda (pembrolizumab) for use with a companion diagnostic made by Dako - PD-L1 IHC 22C3 pharmDx  - which is the first test to determine which NSCLC patients are eligible for treatment. The approval is based on data showing that Keytruda shrank tumours in 41% of pre-treated patients with advanced disease and PD-L1 positive tumours, and that this effect lasted between 2.1 and 9.1 months.

Already approved for advanced melanoma  

Keytruda became the first US-approved PD-1 inhibitor last year when it for the green light for advanced melanoma, and is now also the first and only anti-PD-1 therapy approved for both squamous and non-squamous metastatic NSCLC.

Bristol-Myers Squibb’s rival PD-1 checkpoint inhibitor Opdivo (nivolumab) was approved for squamous NSCLC unresponsive to chemotherapy in the the USA earlier this year.

 The FDA has also approved Gilead Sciences’ Letairis in combination with Eli Lilly’s Adcirca for the treatment of pulmonary arterial hypertension.

The thumbs-up for Letairis (ambrisentan), which is sold by GlaxoSmithKline outside the USA as Volibris and Adcirca (tadalafil) is specifically for the reduction of the risks of disease progression and hospitalisation for worsening PAH, and to improve exercise ability. It was approved as monotherapy back in 2007 while Adcirca got the US green light in 2009.

The approval is based on data which showed that the combination therapy demonstrated superiority over Letairis and Adcirca when used as monotherapy.

The agency has also given the green light to Alkermes’ Aristada, a longer-acting version of blockbuster schizophrenia therapy Abilify, making the treatment available as a once-monthly and six-week injection.

Abilify (aripiprazole), developed by Otsuka Pharmaceuticals Co and sold by Bristol-Myers Squibb outside Japan, is already facing generic competition.

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Pro- and anti-pharma groups fume over Trans-Pacific Partnership

by Admin 6. October 2015 09:39

After years of negotiations, the USA has reached a deal with Japan and 10 other nations on the Trans-Pacific Partnership, a deal which has left pharmaceutical companies and their opponents non-plussed.

The pact creates uniform intellectual property rules and closes thousands of import tariffs. As well as the USA and Japan, the other states are Australia, Brunei, Canada, Chile, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam - in total, the 12 are responsible for about 40% of the world's economic output.

Few details have been released yet but it appears that data protection on new biologics will be set at eight years, down from the 12 years market exclusivity currently in place in the USA. Some other countries, including Australia, had been pushing for an arrangement that will prevent biosimilar competition by only five years.

'Remarkably short-sighted'

Pharmaceutical Research and Manufacturers of America CEO John Castellani said that strong IP protection is necessary for the discovery and development of new treatments and “we are disappointed that the ministers failed to secure 12 years of data protection for biologic medicines, which represent the next wave of innovation”. His view was echoed by Biotechnology Industry Organization CEO Jim Greenwood who claimed that 12 years of data exclusivity “is a prerequisite to attract the investment required to continue medical innovation”, saying “the failure of our Asian-Pacific partners to agree to a similar length of protection is remarkably short-sighted and has the potential to chill global investment and slow development of new breakthrough treatments”.

On the other side of the coin, Médecins Sans Frontières believes this is a terrible deal. Judit Rius Sanjuan, legal policy adviser for MSF’s Access Campaign, spoke of “dismay that TPP countries have agreed to US government and multinational drug company demands that will raise the price of medicines for millions by unnecessarily extending monopolies and further delaying price-lowering generic competition”.

Negative impact on public health 'enormous'

She added that the TPP will “go down in history as the worst trade agreement for access to medicines in developing countries, which will be forced to change their laws to incorporate abusive intellectual property protections for pharmaceutical companies”. Ms Rius Sanjuan went on to say “the negative impact of the TPP on public health will be enormous, be felt for years to come and it will not be limited to the current 12 TPP countries, as it is a dangerous blueprint for future agreements”.

The trade agreement now goes back to the 12 countries for final approval, and Ms Rius Sanjuan said “we urge all governments to carefully consider before they sign on the dotted line whether this is the direction they want to take on access to affordable medicines and the promotion of biomedical innovation”.

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Lilly/Incyte arthritis therapy baricitinib succeeds again

by Admin 1. October 2015 10:35

Eli Lilly and Incyte's rheumatoid arthritis therapy baricitinib has proved to be superior to methotrexate in a Phase III trial, the third of four studies in its development programme.

Top-line results from the BEGIN trial in patients with moderately-to-severely active RA exceeded its primary objective of showing non-inferiority of baricitinib to methotrexate based on an ACR20 response rate (20% improvement in signs and symptoms of RA) after 24 weeks of treatment. It also demonstrated superiority to methotrexate based on ACR20 response and its side effects profile was good.

Baricitinib is a once-daily, oral Janus kinase (JAK) inhibitor and if approved for marketing would compete with Pfizer's Xeljanz (tofacitinib). It has already shown efficacy in RA patients with inadequate responses to traditional disease-modifiying anti-rheumatic drugs and biological therapies.

The fourth trial is a head-to-head comparison with AbbVie's TNF-targeting antibody Humira (adalimumab) and is due to report by the end of the year.

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Roche's Perjeta gets okay in UK for early breast cancer

by Admin 1. October 2015 10:12

The licence on Roche’s Perjeta has been expanded by regulators in the UK to be used by women with early-stage HER2-positive breast cancer.

Perjeta (pertuzumab), which is taken with Roche’s Herceptin (trastuzumab), was initially licensed for previously-untreated advanced HER2-positive breast cancer. It can now also be used pre-surgery for locally advanced, inflammatory or early-stage disease at high risk of recurrence, a move which the company says could help more than 1,800 patients a year in the UK.

Perjeta has already shown the longest survival benefit in patients with previously untreated advanced HER2-positive breast cancer, “so it is very encouraging to see its authorisation in an earlier setting in order to further improve the long-term outcomes for patients with this aggressive disease,” said Andrew Wardley at The Christie NHS Foundation Trust in Manchester.

Perjeta has been deemed too expensive by the National Institute for Health and Care Excellence for routine NHS use, but is still available to patients with previously-untreated advanced disease through England’s Cancer Drugs Fund.

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Roche’s ocrelizumab succeeds in progressive MS trial

by Admin 29. September 2015 14:10

The multiple sclerosis community has reacted with great enthusiasm to the news that Roche’s ocrelizumab is the first investigational medicine to show efficacy in people with  the primary progressive form of the disease in a large Phase III study.

The Swiss major said the trial met its primary endpoint, showing treatment with ocrelizumab significantly reduced the progression of clinical disability sustained for at least 12 weeks compared with placebo. The incidence of serious adverse events associated with ocrelizumab was also similar to placebo.

Roche said added that the positive results for ocrelizumab in both primary progressive and relapsing forms of MS validate the hypothesis that B cells are central to the underlying biology of the disease. It will now submit the data to global regulatory authorities for approval of ocrelizumab in treating both forms of MS in early 2016.

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NICE okays Gilead leukaemia therapy Zydelig

by Admin 29. September 2015 13:45

The National Institute for Health and Care Excellence has approved the use of Gilead Sciences’ chronic lymphocytic leukaemia therapy Zydelig on the National Health Service in England and Wales.

The cost watchdog has published final draft guidance recommending Gilead’s Zydelig (idelalisib) in combination with Roche’s Rituxan (rituximab), for first-line use in untreated CLL patients carrying a 17p deletion or TP53 mutation. It is also recommended for all adults with CLL if their cancer has come back less than 24 months after previous treatment.

The decision follows a preliminary decision earlier this year where NICE asked the company to provide further information on the cost effectiveness of the therapy. Gilead submitted new economic analyses and also proposed a  “simple discount agreement to the list price”.

The Committee concluded that the most plausible incremental cost-effectiveness ratios for Zydelig plus rituximab versus other combinations used by the NHS fell within the range of  £36,000—£46,000 per quality-adjusted life-year gained, and compared to rituximab alone of between £31,000-£41,000 per QALY gained. The mean cost of one’s year treatment of the pill which is taken twice-daily, is £37,922 before the confidential discount.

Zydelig is the first of a new class of therapy that works by blocking the signals which help cancerous cells multiply and survive.

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Bumper month as Europe recommends 19 new medicines

by IainBate 29. September 2015 13:34

Advisors to the European Medicines Agency have recommended approval for a whopping 19 new therapies, including Novartis’ closely-watched heart failure drug Entresto and an antidote to Boehringer Ingelheim’s bloodthinner Pradaxa.

First up, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on Entresto (sacubitril/valsartan), specifically for the treatment of symptomatic chronic heart failure with reduced ejection fraction. The medicine, which was approved in the USA in July, is expected to be a major blockbuster with annual sales expected to be in the region of $4-$5 billion by 2020.

The CHMP also recommended approval of Boehringer’s Praxbind (idarucizumab) as a specific antidote to the German company’s blockbuster bloodthinner Pradaxa (dabigatran etexilate), when rapid reversal of its effect is required.

The green light for Praxbind is important given that Pradaxa is the only novel oral anticoagulant (NOAC) to have a specific reversal agent approved. Antidotes for the other approved NOACs - Bayer’s Xarelto (rivaroxaban), Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban) and Daiichi Sankyo’s Lixiana (edoxaban) are still in the clinic.

Other highlights of the CHMP meeting included backing for two Amgen blood cancer treatments -  Kyprolis (carfilzomib) for multiple myeloma patients whose disease has relapsed after receiving at least one prior course of therapy and Blincyto (blinatumomab) for the treatment of Philadelphia chromosome-negative acute lymphoblastic leukaemia.

The regulator has also backed Roche’s Cotellic (cobimetinib) for use in combination with the Swiss major’s Zelboraf (vemurafenib) in advanced melanoma, GlaxoSmithKline’s Nucala (mepolizumab) for asthma, Vertex’ Orkambi (lumacaftor/ivacaftor) for cystic fibrosis and two AstraZeneca diabetes drugs Ebymect (dapagliflozin/metformin) and Edistride (dapagliflozin).

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