NHS England Overhauls Access to Cancer Treatments

Posted by Tom Penrice on Thu,Jun 30, 2016 @ 06:00 PM

Faster cancer treatment access may result from England's reincarnated Cancer Drugs Fund.Patients in England could have faster access to effective cancer treatments through the reincarnated Cancer Drugs Fund (CDF), the National Institute for Health and Care Excellence (NICE) has announced.

The new fund will replace the existing – and greatly overspent – service, which provides access to cancer drugs that are not routinely available at the National Health Service (NHS) in England. Its costs rose to £340 million between 2015 and 2016, following an annual budget of £200 million when it was set up in 2011.

Devised to counter this overspending, the new system will launch in July, fixing the fund's annual budget at £340 million.

Old CDF Versus New CDF

While the existing CDF can choose to pay for innovative drugs that NICE has rejected for widespread use on the NHS, under the new system the health watchdog will make all the decisions.

In a European first, NICE will issue draft guidance on new cancer drugs or significant new license indications before they have received marketing approval in the UK.

Any drug that receives a positive draft recommendation will be funded from the point of license, with NICE normally issuing final guidance within 90 days of the license. Drugs given a “maybe” rating will be considered for the CDF.

The aim is to bring clarity to decisions about which new cancer drugs will receive NHS funding, as well as to allow the NHS to offer conditional funding for those with uncertain evidence for use.

Sir Andrew Dillon, NICE chief executive, commented in a press release: “Patients in this country will now have access to clinically and cost effective, innovative new cancer drugs faster than ever before.”

He added: “In a first of its kind approach, NICE will issue draft recommendations on the use of cancer medicines before they receive their license, with funding from NHS England available if approved. No other country in Europe does this.”

Impact on the pharma industry

If the case for routine use of a drug is not clear cut and more evidence is needed to prove its cost effectiveness, NICE can recommend the drug for temporary, conditional use in the new CDF.

The drug will remain available in the CDF for up to two years while the manufacturer gathers evidence to show that the medicine works and is fairly priced.

After two years, NICE will conduct a review to consider the drug for routine commissioning on NHS England, with the medicine moving out of the CDF and into routine budgets, or being made available on an exception only basis. 

Dillon argued: “The new CDF will be fair. Companies will be given the opportunity to demonstrate their drugs will benefit patients and bring value to the NHS.”

However, concerns about the new fund have been raised, with claims that NICE’s appraisal process could block access to drugs. The Pharma Times reported that the Association of the British Pharmaceutical Industry was disappointed by NHS England’s decision to push ahead with proposals that carry a “very real risk of significantly setting back patient access to cancer medicines, now and for the foreseeable future”.

Paul Catchpole, value and access director of the Association, told the journal: “If cancer medicines go through more or less exactly the same NICE appraisal process that was in place five years ago - which necessitated the setting up of the CDF in the first place - we will largely get the same answers as before - the majority of medicines will be turned down”.

He warned that under the proposals, two thirds of existing CDF medicines would be likely to no longer be available to NHS patients by the end of the year.

Cancer charities agree. In a letter to the British prime minister published in newspaper The Daily Telegraph, 15 charities wrote that many drugs available the western world would "now struggle to gain approval" in England due to NICE’s “last-century methodology”.

The letter stated: "Unfortunately the new system does not update the methodology used by NICE, introduced back in 1999, and many clinically-effective treatments will now struggle to gain approval.”

The charities highlighted that since 2011, when it was launched, the CDF has paid for 84,000 cancer treatments that NICE turned down. Speaking to the BBC, Baroness Delyth Morgan, chief executive of charity Breast Cancer Now, commented: "Not a single breast cancer drug has been considered cost-effective by NICE in the last seven years and this simply cannot continue." Among the breast cancer drugs NICE has rejected is Kadcyla, a treatment which can prolong a dying patient’s life by six months on average.

Cancer Research UK explains on its website that NICE’s approval process is based on whether a drug works, whether it is cost effective and contributions from patient organizations, health professionals and experts.

Important Dates

The current CDF closed on 1 April 2016. Drugs transferring from the old CDF will be appraised by NICE over the next 18 months. Entirely new drugs will be able to enter the CDF from July 2016.

All drugs on the existing CDF list will continue to receive funding until the point that NICE has completed a new appraisal of them, and any patients currently receiving them will finish their treatment.

The CDF was established in 2011 and covers England.

This article is a synopsis of: Faster access to effective cancer treatments through new Cancer Drugs Fund, Cancer Drugs Fund changes deeply concerning, say charities, and What is NICE and how does it work?

Pennside Partners Expands European Presence through new UK office located South of Manchester

UK-Headquarters-Pharma-Biotech-Consulting-Firm-B650.jpgThe Pennside team is excited to announce their new office in Alderley Edge in the UK, 25 KM south of Manchester. This ideal location will help us better serve our European client base due to its proximity to local pharma and biotech companies. Thomas Penrice, Vice President and Partner will be the EU Managing Director. Learn more

Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Cancer Drug Development, Cancer

T-Cell Immunotherapy Market Predicted To Grow

Posted by Tom Penrice on Thu,Apr 21, 2016 @ 06:00 PM

Immunotherapeuticsis projected to be a $30 billion USD market by 2030.Nearly one million people are diagnosed with cancer in the United States per year, according to The American Cancer Society, and although cancer therapeutics are among the most active areas in drug development, treatment still falls short of meeting patients’ needs.

However, experts believe that immunotherapeutics – in particular T-cell immunotherapy – could help fill a vital gap, with Roots Analysis’ "T-Cell Immunotherapy Market, 2015-2030" report predicting the market will be worth $30 billion USD by 2030. 

Robust products in T-cell immunotherapy

Shannon Flynn, a consultant at Pennside with 3 years’ experience in gene therapy, explains that T-cell immunotherapy is an emerging therapeutic modality in which tumor-targeting T-cells are administered to the patient as a sort of “living drug.”

The therapy involves collecting T-cells, either from the patient (autologous) or a donor (allogeneic), as the active ingredient for treatment.  The cells are then modified to enhance their anti-tumor potential, before being expanded to increase total cell numbers for an optimized final product which can be administered to the patient.

Separated into three segments – CAR-T, TCR, and TIL therapies, the market is characterized by a robust pipeline of products targeting hematological cancers and solid tumours.

Researchers identified more than 180 T-cell therapies across various phases of development: at 56%, CAR-T therapies are the most common – and likely to gain the most attention – followed by TCR (25%) and TIL (19%) therapies. Engineered CAR-Ts with switch technologies are among the latest additions to the T-cell immunotherapy pipeline.

Pennside’s analysts note that some of the most recent developments in the field involve engineering CAR-T cells with sophisticated switch technologies which serve to modulate the activity of the cells in vivo. These technologies are primarily aimed at improving safety of the cells by migrating on-target/off-tumor toxicities.

For example, cells can be designated to turn “on” or “off” in the presence of a small molecule drug, while others might be engineered to activate only in response to stimuli from the tumor itself. Novel technologies such as these afford the CAR-T cells with mechanisms to enhance their tumor targeting potential and avoid damaging healthy tissues.

Driving factors behind T-cell developments

As for progress, the numbers speak for themselves: the report identified investments in T-cell research nearing USD 3 billion across start-ups and small firms. Big industry players are also driving research in the field.

Further helping push the T-cell market forward are lucrative rounds of VC funding, the discovery of novel targets, encouraging clinical trial results, and developments in immunotherapy products.

Meanwhile, various providers have pioneered improved efficacy and safety in developing platforms for engineering T-cells. The market has also attracted interest from technology providers with capabilities in genome editing, and viral and non-viral gene transfer. Other providers are developing innovative safety switches to manage side effects, such as cytokine release syndrome and B-cell aplasia.

The report, published by Roots Analysis, provides a comprehensive view of the market, which is still in its infancy.

This blog is based on the press release: http://www.prnewswire.com/news-releases/t-cell-immunotherapy-market-2015-2030-300234571.html and report http://www.rootsanalysis.com/reports/view_document/t-cell-immunotherapy-market-2015-2030/108.html

Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: T-Cell Immunotherapy, Cancer Therapeutics, Cancer, Immunotherapy, Immunotherapeutics

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