domingo, 13 de septiembre de 2015

UK Cuts Cancer Drugs; 'Hammer Blow', 'Stupid,' Say Critics

Medscape Medical News > Oncology
UK Cuts Cancer Drugs; 'Hammer Blow', 'Stupid,' Say Critics
Liam Davenport
September 09, 2015


The United Kingdom continues to whittle down the number of cancer drugs it will pay for; 16 more agents were cut this week from a list of funded therapies.

Strong reactions to the painful news have come from industry and nonprofit organizations.

"These cuts will be a hammer blow to many thousands of desperately ill cancer patients and their families,"
said Andrew Wilson, chief executive of the Rarer Cancers Foundation in London, United Kingdom, according to an article published in BBC News.

The cuts prompted harsh words from a pharmaceutical executive whose company was affected.
Severin Schwan, PhD, chief executive officer of Roche, called the move "stupid" and "completely arbitrary" in a press briefing at company headquarters in Switzerland, according to news reports.

Dr Schwan argued that the benefit of the drugs will lead to potential savings to the health system in the United Kingdom.

Roche's blockbuster bevacizumab (Avastin) will no longer be paid for by the government for the treatment of cervical, breast, and colorectal cancer. Roche's trastuzumab emtansine (Kadcyla), for the treatment of metastatic breast cancer, will also be cut.

The drugs have been eliminated from approved treatments on the National Cancer Drugs Fund (CDF) List.
The CDF was established to provide access to cancer drugs deemed not to be cost-effective by the National Institute for Health and Care Excellence (NICE), the health watchdog in the United Kingdom that advises the National Health Service (NHS).

The 16 drugs will be removed from the CDF list on November 4. They cover 23 indications, including chronic lymphocytic leukemia, recurrent or metastatic cervical cancer, advanced breast and colorectal cancer, metastatic renal cell carcinoma, and relapsed and refractory multiple myeloma.


The CDF was originally set up at the behest of Prime Minister David Cameron, and has enabled more than 55,000 cancer patients to receive drugs that they otherwise would have had difficulty accessing.

Although it was broadly welcomed by doctors, charities, and patient groups, the CDF has been controversial from the start. In fact, the very concept of such a fund was questioned by some experts.

The current reduction in the list of available drugs joins a previous cull of 21 cancer drugs for 25 indications earlier this year. As before, patients currently receiving the drugs to be removed from the CDF will continue to do so.

The CDF's budget grew from £200 million (US$307 million) in 2013/14 to £280 million (US$430 million) in 2014/15, and to an estimated £340 million (US$522 million) in 2015/16 — an increase of 70% over 2 years, as previously reported by Medscape Medical News.
Without removing the drugs from the approved list, current projections suggest that spending on the CDF would increase to around £410 million (US$630 million) for this year alone, according to a news release from NHS England, which runs the CDF.
"All decisions on drugs to be maintained in the CDF were based on the advice of clinicians, the best available evidence, and the cost of the treatment," according to NHS England.

"There is no escaping the fact that we face a difficult set of choices, but it is our duty to ensure we get maximum value from every penny available on behalf of patients," said Peter Clark, MA, MDchair, from the CDF.
"We must ensure that we invest in treatments that offer the most benefit, based on rigorous evidence-based clinical analysis and an assessment of the cost of the treatments," he added.

But patient advocates see things differently
. According to Wilson, from the Rarer Cancers Foundation, government officials said "they wanted to work with charities to develop a solution, but now the NHS has announced big reductions in access to existing life-extending treatment, with no action to make available the newest game-changing drugs."
"Thousands of breast cancer patients have today been denied the chance of improved quality of life and extra time with their loved ones. This news is devastating for them," Samia al Qadhi, from Breast Cancer Care, was quoted as saying in The Guardian.

"The Cancer Drugs Fund is falling apart when there is still no long-term solution in place,"
she added.
Notably, pharmaceutical companies can get their drugs back on the list if they offer them at a lower price.
"The CDF has been seen as a 'back door' to funding high-cost cancer drugs on the NHS," said Charlotte Chamberlain, MD, clinical research fellow at the School of Social and Community Medicine, University of Bristol, United Kingdom, according to The Guardian article.
"Introducing negotiations with pharmaceutical companies over cost is overdue to prevent further unsustainable costs for the NHS," she added.

Moreover, novel drugs continue to be approved for use on the NHS; the anti-PD-1 checkpoint inhibitor pembrolizumab (Keytruda, Merck) was cleared for use in the treatment of advanced melanoma.

The drug is the first to be approved through the Early Access to Medicine Scheme of the Medicines and Healthcare Products Regulatory Agency, which aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization when there is a clear unmet medical need.

Although pembrolizumab is reported to cost approximately US$150,000 per patient per year, the manufacturers have agreed to a patient-access scheme with the UK Department of Health, which discounts the list price of pembrolizumab at the point of purchase or invoice.
The level of discount is confidential.

In addition to the drugs being removed from the list, peptide receptor radionuclide therapy for the treatment of advanced neuroendocrine tumors will also be removed on November 4.



Table. Drugs to Be Removed From the CDF on November 4
Drug
Indications



Albumin bound paclitaxel
First-line treatment of advanced adenocarcinoma of the pancreas in combination with gemcitabine

Bendamustine
Chronic lymphocytic leukemia 
Relapsed mantle cell non-Hodgkin's lymphoma

Bevacizumab
First-line treatment of recurrent or metastatic cervical cancer in combination with chemotherapy 
Advanced breast cancer 
Second- or third-line treatment of advanced colorectal cancer

Bosutinib
Refractory chronic-phase chronic myeloid leukemia 
Refractory accelerated-phase chronic myeloid leukemia 
Accelerated-phase chronic myeloid leukemia when there is intolerance to other treatments

Brentuximab

Refractory systemic anaplastic lymphoma 
Relapsed or refractory CD30+ Hodgkin's lymphoma

Cetuximab

Third- or fourth-line treatment of metastatic colorectal cancer as a single agent

Dasatinib

Philadelphia chromosome-positive acute lymphoblastic leukemia

Everolimus

Metastatic renal cell carcinoma

Ibrutinib
Relapsed/refractory chronic lymphocytic leukemia 
Relapsed/refractory mantle cell lymphoma

Lenalidomide
Second-line treatment of multiple myeloma

Ofatumumab

Chronic lymphocytic leukemia

Panitumumab

Third- or fourth-line treatment of metastatic colorectal cancer as a single agent

Pegylated liposomal doxorubicin
Named sarcomas

Pomalidomide

Relapsed and refractory multiple myeloma

Radium-223 dichloride

Castration-resistant prostate cancer in patients with bone metastases
Trastuzumab emtansine
HER2-positive locally advanced/unresectable or metastatic (stage IV) breast cancer

No hay comentarios: