The termination of the Cancer Drug Fund this year leaves doctors and patients uncertain of drug provision in the future, MPs have said.

The Health Select Committee has asked the Government to clarify its ‘nebulous’ proposals for a value-based pricing (VBP) system for NHS drugs by March.

However, the Government has replied that it is still negotiating with the ABPI to agree the terms for value-based pricing.

The Cancer Drug Fund, which helps trusts to purchase cancer drugs that are licensed but not currently approved by NICE, has given more than 25,000 patients access to innovative cancer drugs since its introduction in 2011.

The Fund ends this year, and its replacement through VBP in 2014 does not guarantee continued patient access to those drugs.

Stephen Dorrell (pictured), chair of the Health Select Committee, commented: “What we were told during our inquiry indicates that the move to value-based pricing of drugs will be a more modest change than has been suggested, but there is a lack of clarity around the whole issue which has persisted too long.

“Where an individual patient is on a course of treatment it is important there isn't a cliff edge, that the patient has continuity of care.”

The Department of Health has promised to “ensure arrangements are in place to protect individual patients who are receiving treatment with drugs funded by the Cancer Drugs Fund as the end of the fund approaches.”

The statement did not imply that new patients would have access to the drugs covered by the Cancer Drug Fund beyond 2013.

The DH spokesman added: “As negotiations between the Department of Health and the Association of the British Pharmaceutical Industry are under way, it would be inappropriate to comment further at this stage.”

An experimental cancer drug can act as a ‘searchlight’ for HIV that is latent in the body, exposing it to antiretroviral therapy.

The experimental drug JQ1 was developed at Harvard Medical School as a treatment for cancer, but may have further applications.

JQ1 may be able to reactivate latent HIV, which is otherwise highly resistant to drug therapy.

While antiretrovirals have succeeded in prolonging the lives of many people infected with HIV by reducing their bloodstream ‘viral load’, eradicating the virus is rarely possible.

Researchers at Boston University added JQ1 to latently HIV-infected cells and observed strong reactivation of the virus.

“This drug may be useful as adjunctive therapy in efforts to purge latent HIV reservoirs to eradicate infection,” said Monty A. Montano, principal investigator at the Section of Infectious Diseases, Boston University Medical Campus.

John Wherry, Deputy Editor of the Journal of Leukocyte Biology, noted that HIV drug research has been “a series of incremental steps” with drugs developed separately working in combination.

“The hope is that the ability of JQ1 to make latent HIV ‘visible’ to other HIV drugs will be another cog in the gearwheel of an HIV cure,” he concluded.

Specialty pharmaceutical company AP Pharma has appointed the former global head of oncology at Bayer Healthcare as its senior VP and Chief Commercial Officer.

Robert Rosen will lead the launch of APF530, AP Pharma’s drug to prevent chemotherapy-induced nausea and vomiting.

He will become a director of the company once the drug has successfully establishes a market presence.

John Whelan, President and CEO of AP Pharma, said: “Robert’s deep and extensive experience commercialising oncology drugs will be instrumental as we enter the commercialisation phase of the company.”

AP Pharma specialises in developing injectable drugs using its Biochronomer polymer-based drug delivery platform, which can reduce the frequency of injection from daily to weekly or fortnightly.

APF30, the company’s lead product, is used to prevent both acute-onset and delayed-onset nausea and vomiting caused by chemotherapy.

Rosen led Bayer’s cancer drugs operation from 2005 to 2011 – including the launch of Nexavar (sorafenib) for the treatment of renal cancers.

Before that, he was VP of oncology at Sanofi-Synthèlabo, where he was responsible for launching the colon cancer drug Eloxatin (oxaliplatin).

Value-based pricing (VBP) is a more fair and balanced way of supplying life-saving drugs for patients than the Government’s Cancer Drugs Fund, a new study shows.

Research by the University of Bangor found that out of more than 4,000 people across Britain 64% agreed that the NHS should not pay more for cancer drugs compared to medicines for other threatening conditions.

Professor Dyfrig Hughes, study author, said “singling out cancer seems to be unfair, but is something which will hopefully be addressed in the value-based pricing system, which has public support.”

The Cancer Drugs Fund was introduced two years ago for the NHS to treat patients with oncology treatments not currently recommended by NICE. It supplies £200m a year until 2013 to pay for drugs.

VBP is the Government’s alternative to the existing 2009 PPRS pricing scheme – set to expire in 2013. It will allow government to set prices for new medicines as they enter the UK market – and set new definitions of value.

Although it has gained support from the general public, the ABPI has raised a number of concerns about the new system and is in negotiations with the Government to create an amended version.

“The funding of high cost cancer treatments is clearly an emotive issue, and it is for politicians to determine the parameters by which the NHS pays for them, however, there are equally distressing conditions affecting patients who are equally deserving, but they have no access to ring-fenced budgets,” said Professor Hughes.

The Rarer Cancers Foundation (RCF) has called for action to ensure that when the Cancer Drugs Fund ends, access to drugs for rare cancers continues.

Over 16,000 NHS patients per year may lose access to life-extending drugs when the fund ceases in March, the charity warns.

It suggests that a “transitional” continuation of the Cancer Drugs Fund (CDF) may be needed while steps are taken to ensure that new pricing and prescribing arrangements maintain these treatments.

The CDF provides £200m per year for trusts to purchase cancer drugs that do not have NICE approval.

According to the RCF’s new report on the fund’s impact, it has enabled over 3,600 patients with rarer cancers to access treatments in the last year.

The report points out that the fund has enabled NICE to increase its cancer drug rejection rate from 40% to 60% by making cost a higher priority.

It recommends that NHS authorities examine variations in access to cancer drugs according to location and age, leading to “an urgent review” by the NHS CB of “population cohort policies for funding cancer treatments”.

The RCF also calls for “national protocols” for off-label cancer treatments to be established, allowing their efficacy and safety to be assessed.

Looking forward, it says the DH “should clarify as a matter of urgency how it intends to ensure access to treatments currently reimbursed through the Cancer Drugs Fund in 2014 and beyond.”

The review proposes two measures:

• a mechanism to include these treatments in the new value-based pricing framework, with the CDF being extended as a “transitional” system if necessary

• a national system for off-label prescribing of rare cancer drugs that cannot be covered by VBP.

The use of combination therapies in the treatment of cancer patients is set to increase in the future, according to a new report.

Analysis found that oncological treatments are evolving to include biologic medication, which, in combination with cytotoxic drugs, is rapidly becoming the top pharmaceutical therapy.

GBI Research’s report found the effective capabilities of biologics in controlling and treating complications has led to their widespread use and popularity amongst patients and prescribers.

The cytotoxic therapies markets has eight major indications and brands include Taxotere (docetaxel), Alimta (pemetrexed) and Xeloda (capecitabine) – all of which have exceeded sales of $1 billion.

However, these drugs are set to be exposed to generic competition in coming years which will reduce the cost of combinational treatments.

The popularity of such treatments is also expected to convince pharmaceutical companies to apply for label extensions on their existing biologics portfolio for multiple oncology complications.

This, the report said, will support the continued development of cytotoxic drugs in the future, despite significant safety hurdles that have previously led to weak pipelines.

The cytotoxic therapies market accounted for $6.5 billion in revenue ten years ago. It grew at an annual rate of 5.8% to reach $10.1 billion in 2010. The report now expects generic competition to reduce revenues in the market by 2017 to $7.6 billion – despite predicted uptake.

Cancer patients are not prescribed the most appropriate treatment for their disease due to a lack of access in receiving biomarker test results, a new report has found.

Market research from 100 oncologists found that more than half of cancer specialists (53%) admit to prescribing a treatment which is not necessarily the most appropriate due to a lack of data.

Dr Tim Iveson, Consultant Medical Oncologist, Southampton General Hospital and member of Bowel Cancer UK's Medical Board, says the findings are “extremely worrying”.

The report – conducted by Merck Serono – also reveals that a further 40% of specialists said they were unable to prescribe the best appropriate treatment due to delays in biomarker tests results.

Biomarker tests are crucial in determining whether a personalised treatment may be more effective than standard options.

However, nearly three quarters (74%) of specialists either agree or strongly agree that biomarker tests differ between in availability regions after 22% of respondents admitted to prescribing personalised medicines without appropriate biomarker tests.

Almost half of respondents said the biomarker test results take at least two weeks to be returned and the unsatisfactory delay risks treatments being interrupted, potentially impacting outcomes.

Additionally, the report found that almost one in four doctors (22%) were more likely to offer personalised medication to private patients as opposed to an NHS one.

Dr Iveson said the findings were “simply not acceptable” and called for more partnerships between the NHS and pharma to ensure patients are given the same level of treatment across the country.

“In bowel cancer, we are making headway, with biomarker testing standardised and provided to every patient by the pharmaceutical industry,” he commented. “We need more collaborations like this between the NHS, the pharmaceutical industry and Government to ensure better use of stretched NHS resources and to make sure that individual patients are receiving the very best treatment possible that will lead to the best outcomes and where possible extend life.”

The report was sent to MPs on the same day the DH revealed new guidance on the Cancer Drugs Fund in an attempt to increase the speed with which patients receive treatment.

A new £50m investment fund aims to help UK companies bridge the translation gap between cancer drug discovery and early-stage product development.

The CRT Pioneer Fund, with equal contributions from Cancer Research Technology (CRT) and the European Investment Fund (EIF), aims to take cancer drug candidates from discovery through to phase II clinical trials.

The new fund was welcomed by the Bioindustry Association (BIA), the trade association for the UK bioscience sector, who said it came at “a particularly good time for life sciences in the UK”.

The fund’s starting capital of £25m will be doubled by the founders and/or potentially other investors.

CRT is the commercial arm of Cancer Research UK, whose widespread research networks will provide projects for the investment of at least two-thirds of the new fund, with the rest coming from other academic groups or industry.

David Willetts (pictured), Minister for Universities and Science, said: “In our Strategy for UK Life Sciences we set out ambitious plans to build on the success of the industry by fostering collaboration between our excellent research base and businesses. This initiative from Cancer Research Technology and the European Investment Fund will complement this work extremely well.”

“The creation of this landmark fund addresses the problem of funding the development gap which is restraining cancer drug development in the UK,” said Dr Keith Blundy, CEO of CRT.

“This important investment means we can take forward the most innovative approaches using our in-house drug discovery and development capabilities, to progress promising treatments from the lab all the way to clinical trials, translating our world-class scientific research into new treatments more quickly.”

Richard Pelly, EIF Chief Executive, noted: “This investment targets a stage of the investment spectrum often neglected by the market. The CRT Pioneer Fund will primarily follow a licensing model rather than creating companies.”

Glyn Edwards, BIA Interim Chief Executive, commented: “The launch of the CRT Pioneer Fund will provide another financing option for companies and academics in the UK looking to translate their cancer drug discoveries into clinical development.

“The fund arrives at a particularly good time for life sciences in the UK, following the launch last week by the Wellcome Trust of a £200 million venture fund and GlaxoSmithKline’s decision to invest £500 million in biopharmaceutical manufacturing in the UK.”

Sanofi has lost a legal appeal against the decision that Roche and Biogen Idec did not infringe its patent for biologic drug development.

Roche’s Genentech business and biotech specialist Biogen Idec did not steal Sanofi’s IP for genetic medicine to develop the cancer drugs Avastin and Rituxan, a US appeals court determined.

The decision reflects the growing commercial potential of biologics and the tense relationship between big pharma and the biotech sector.

The dispute began in 2008, when Genentech cancelled its long-standing licensing agreement with Sanofi. The genetic medicine specialist was acquired by Roche in 2009.

Sanofi claimed that Genentech and Biogen Idec had used its proprietary techniques to enhance gene expression, improving the efficiency of drug production.

However, the US court upheld the previous decision that in both cases, the drug production methods were different from those covered by Sanofi’s patent.

Avastin and Rituxan, both cancer drugs, are among Roche’s best-selling products: Rituxan achieved sales of $6.6bn, and Avastin $5.81bn, in 2011. Avastin is marketed by Roche, while Rituxan is co-marketed with Biogen in the US.

According to Sanofi spokesperson Carrie Brown, the company is “currently evaluating its options and next steps.”

Elderly cancer patients are being denied standard treatment options because of their age, a new report has found.

Macmillan Cancer Support’s The Age Old Excuse: the under treatment of older cancer patients exposed levels of discrimination within elderly patients due to ‘ill-founded assumptions’.

Ciarán Devane, Chief Executive of Macmillan Cancer Support, says the practice of recommending treatment based on age instead of a patient’s health is “an unacceptable act of discrimination”.

Currently, there are approximately 310,000 people diagnosed with cancer and around 156,000 deaths in Britain each year. It is the biggest killer of people aged 75 and over.

The amount of people dying from cancer is reducing in most age groups. However, the report found the number of deaths is reducing at a slower rate in those aged 74 to 84, and death rates in those aged 85 and over are increasing.

Research published in Cancer Epidemiology says there could be 14,000 fewer deaths from cancer in those aged 75 and over if mortality rates from cancer matched those in the US.

Macmillan is now calling for a more effective way of assessing older people for treatment and suggests short-term practical support to enable an uptake in recommended treatments. The charity also says training is needed for healthcare professionals working with elderly patients within the NHS to end the discrimination they currently face.

“We have a moral duty to treat people as individuals and give them the best chance of beating cancer, regardless of their age,” commented Ciarán Devane.

“As our population ages, and the number of people diagnosed with cancer grows, it is vital that steps are taken to ensure that the right people get the right treatment at the correct level of intensity, together with the practical support to enable them to take up and complete the treatment.

“Efforts are being made to increase early diagnosis and promote healthier lifestyles, but much more needs to be done to tackle under treatment.

“The NHS and social care providers must wake up to the specific issues older people face and ensure treatment decisions are based on their overall health not just their date of birth. Writing people off as too old for treatment is utterly shameful.”

Paul Burstow, Care Services Minister, says that cancer patients of all ages should “expect the best care”, but insisted the NHS already provides this.

“We are under no illusions that there are unjustifiable variation in standards, which is why we have funded five pilots jointly with Macmillan to help us understand how older people with cancer are cared for,” he said.

“The learning from the pilots will help the NHS to ensure that all older patients with cancer have their needs properly met.

“Not only is the NHS under a moral obligation not to discriminate, but we sent a clear message that any age discrimination in the NHS is unacceptable when we did not ask for any exemptions on age in the Equality Act.”