Khalid Younis – A Letter From Number 10

In October I wrote this letter to David Cameron, our Prime Minister.

Dear Prime Minister,

The photo below is of me with my new friend, his name is Khalid Younis. We both have a rare form of leukaemia called Chronic Myeloid Leukaemia (CML). Treatment for CML was revolutionised in 2001 when Time magazine hailed a drug called imatinib a magic bullet against cancer. Now, 14 years later, my friend cannot access a new, potentially life-saving drug called ponatinib because it hasn’t been appraised by NICE.

Khalid Younis and Kris Griffin

I don’t understand why the cancer drug fund process was closed alongside the appraisal process, we find ourselves falling through an administrative gap. Khalid’s situation has attracted nearly 8,000 signatures on a petition and the story has been featured in the Daily Mail, Daily Mirror and the local Birmingham newspapers. We’ve contacted Khalid’s MP, Roger Godsiff and my MP, Mark Garnier. Mark knows my work and has always been really supportive.

Whilst I realise you have many responsibilities and must receive many letters like this; if you have time to meet or discuss this issue and help us I would be extremely grateful.

Ponatinib offers the last real hope Khalid has, not being able to access it in England is devastating.

Yours sincerely,

Kris Griffin (Mr)

Last week I received this reply:

Of course I’m disappointed, I’m not sure if I ever thought he’d agree to a meeting and fix the problem. My issue with this letter is that the Department of Health is part of the problem. They’ve allowed this issue to manifest and within the space of two days (last week) I’ve managed to extract three different dates when they expect the appraisal process to be ready. Not ready for use…oh no..ready for it to be reviewed. In the meantime, we don’t have an appraisal process and by that point we won’t have a cancer drugs fund. I don’t want to write a ‘told you so’ letter to our PM.

So, I’ll be writing to Mr Cameron again, perhaps I’ll also include the 8,000 signatures on this petition and ask him what he thinks the Department of Health will do; because from where I’m sitting they are making the situation worse.

Kris Griffin – Access CML Drugs

More Parliamentary questions answered.

My thanks again go to Mark Garnier MP for asking these written questions for us in Parliament. It’s vitally important that we keep asking questions, forcing answers (even if we don’t like them) and giving this cause as high a profile as we can manage. These answers are recorded for posterity in Hansard and we can refer back to them any time. Hansard is the name of the printed transcripts of parliamentary debates in the Westminster system of government. It is named after Thomas Curson Hansard, an early printer and publisher of these transcripts.
Kris

22 Apr 2013 : Column 753W
Leukaemia

Mark Garnier: To ask the Secretary of State for Health (1) what steps he has taken to ensure that those diagnosed with chronic myeloid leukaemia have access to a wide range of treatment options, including Dasatinib’ [151773]

(2) what recent discussions he has had to ensure that those diagnosed with chronic myeloid leukaemia have access to a wide range of treatment options, including Dasatinib. [151774]

Norman Lamb: The Mandate to NHS England clearly states the need to improve access to treatment for people when they need it.

The National Institute for Health and Care Excellence (NICE) has issued technology appraisal guidance that recommends the drugs imatinib and nilotinib for use in the treatment of chronic myeloid leukaemia. NICE guidance does not recommend dasatinib as a clinically and cost-effective use of national health service resources.

Commissioners are under a statutory obligation to provide funding for such treatments and drugs recommended by NICE within three months of the guidance being published.

Patients have a right under the NHS Constitution to clinically appropriate drugs and treatments recommended by NICE technology appraisal guidance.

Since October 2010, the £650 million Cancer Drugs Fund has helped over 28,000 patients in England to access the drugs their clinicians believe will help them. NHS England has now taken on oversight of the fund, bringing even greater consistency to decision making.

The Secretary of State for Health, the right hon. Member for South West Surrey (Mr Hunt), has had no recent discussions about this matter.

http://www.publications.parliament.uk/pa/cm201213/cmhansrd/cm130422/text/130422w0007.htm#13042383001683

 

22 Apr 2013 : Column 735W
Cancer: Drugs

Mark Garnier: To ask the Secretary of State for Health with reference to the Cancer Drugs Fund, as announced by the NHS Commissioning Board, whether access to some treatments previously available through the fund will be restricted. [151790]

Norman Lamb: Since NHS England took on oversight of the Cancer Drugs Fund from 1 April 2013, it has published a national list of cancer drugs covered by cohort policies on its website at:

www.england.nhs.uk/wp-content/uploads/2013/03/ncdf-list.pdf

We understand that the great majority of cancer drugs previously funded by strategic health authority panels are on this cohort policy list, supporting timely and consistent access. Clinicians can apply to the national Cancer Drugs Fund for the inclusion of a drug within the approved cohort list.

Regional clinical panels will continue to consider individual patient applications where a patient is considered to be exceptional to a cohort, policy or where use under a cohort policy has not been considered due to the rarity of the condition.

http://www.publications.parliament.uk/pa/cm201213/cmhansrd/cm130422/text/130422w0006.htm#13042383001615

Event: Leukaemia and Lymphoma Research Impact Day 13th April 2013

I’ll be speaking at this free event so please come and say hi if you spot me. Thanks, Kris

“We won’t be satisfied until every patient with blood cancer can live fully the life that they were given; a life where the diagnosis of a blood cancer has no impact.

In the 53 years since we started the journey to beat blood cancer, our mission has never been clearer: we stop people dying from blood cancer; we make patients’ lives better and we stop people getting blood cancer in the first place.

In 2013, thanks to the collaborative efforts of many throughout the world, survival has improved dramatically since research began in blood cancer, but there is still work to be done both in saving more lives and minimising the impact on the quality of life of patients before and after treatment.

Join us in London on 13 April to hear how we are doing, meet some of the amazing people involved and discover why there has never been a better time to make a positive impact on the world.”

Event details

Date: Saturday, 13 April 2013
Time: Starts at 9:00 am

Location:
Tower Hotel
St Katharine’s Way
London
E1W 1LD

http://leukaemialymphomaresearch.org.uk/event/special-events/impact-day-2013

Foreseeing a Cure for CML – interview with Dr. Baccarani

Many patients with CML are now living well while taking powerful medicines that keep the disease in check. Researcher Dr. Michele Baccarani, from Italy, thinks that even a few years of taking medicine could enable some patients to cease therapy and remain in overall good health. For other patients, concern still remains in those who develop resistance to today’s approved medicines, cannot tolerate the effects of the medicine or develop the T315i mutation. In this interview from the Controversies in Hematology 2012 in Barcelona, Dr. Baccarani explains his hope for these patients with the use of Ponatinib.

Source: Patient Power

Cancer drugs fund usage

I thought that you would be interested to see the figures published by the Department of Health and the accompanying NCAT bulletin, which provide details of the number of successful applications made through the Cancer Drugs Fund. Currently 18,500 applications have been approved, with the majority through the permanent cancer drugs fund. I have included below a table that shows the number of treatments and money spent by each SHA through the CDF.

Whilst there is no specific mention of Dasatinib, the NCAT bulletin does reveal that it is not within the top ten drugs requested via the Cancer Drugs Fund, which make up a total of the 80% of successful applications.

Should you require any further details, the Department of Health statement can be found at the links below:

http://mediacentre.dh.gov.uk/2012/08/29/cancer-drugs-fund-usage/

http://ncat.nhs.uk/sites/default/files/uploaded/CDF%20National%20Bulletin%20Summer%202012.pdf

Strategic health authority	Number of patients funded 2010-11	Amount spent 2010-11 £0002	Number of patients funded 2011-12	Amount spent 2011-12 £0002	Number of patients funded 2012-13 to end June 2012	Amount spent 2012-13 to end June 2012 £000	Total number of patients funded Oct 2010 to end June 20121
North East	420	5,249	696	6,834	119	888	1,235
North West	266	7,400	1,044	10,015	360	3,669	1,670
Yorkshire and the Humber	178	1,400	809	4,926	636	388	1,623
East Midlands	178	3,157	871	9,624	240	332	1,289
West Midlands	292	2,400	1,658	14,062	416	6,470	2,366
East of England	246	4,286	1,486	12,659	420	4,500	2,152
London	443	5,915	1,364	20,560	392	7,263	2,199
South East Coast	306	2,159	1,241	10,765	243	4,785	1,790
South Central	290	3,200	1,170	5,318	192	858	1,652
South West	161	3,088	1,459	13,565	890	5,187	2,510
Total	2,780	38,254	11,798	108,327

Final set of Parliamentary Questions answered

The final set of PQs tabled by Mark Garnier MP were answered by the now former health minister Paul Burstow MP and relate to the number of patients receiving dasatinib on the CDF (Cancer Drug Fund), access that patients have at different stages of disease progression and the Department of Healths long-term plans on funding Dasatinib. Full details of these results can be found below.

A huge note of appreciation to Mark Garnier, the MP for Wyre Forest, who has been so supportive of my efforts to ask the right question to the right people.

Although the answers are the same stock response trotted out at every opportunity, in particular hiding behind NICE decisions, there are some reassurances given about availability of dasatinib.

Kris

Mark Garnier: To ask the Secretary of State for Health how many patients have received the drug dasatinib on the Cancer Drugs Fund since the fund was created in 2010. [117336]

Paul Burstow: Under the interim cancer drugs funding arrangements in 2010-11 (from October 2010 to the end of February 2011), five patients received dasatinib. Patient numbers by drug for March 2011 are not available. Based on the latest available information, a further 56 patients have received dasatinib under the Cancer Drugs Fund (from April 2011 to the end of February 2012).

http://www.publications.parliament.uk/pa/cm201213/cmhansrd/cm120903/text/120903w0009.htm#12090429002131

Mark Garnier: To ask the Secretary of State for Health (1) what steps his Department plans to take to ensure that chronic myeloid leukaemia patients have a wide range of treatment options (a) when newly diagnosed and (b) at the second line of treatment; [117335]
(2) what long-term plans his Department has to ensure that those diagnosed with chronic myeloid leukaemia have access to a wide range of treatment options after the end of the Cancer Drugs Fund in 2014. [117337]

Paul Burstow: ‘Improving Outcomes in Haematological Cancers’, published by the National Institute for Health and Clinical Excellence (NICE) in 2003, makes recommendations on the treatment, management and care of patients with haematological cancers. The guidance makes recommendations on first and second line treatments for chronic myeloid leukaemia (CML). Our Cancer Outcomes Strategy, published on 12 January 2011, makes it clear that the NICE guidance will continue to be a feature of all commissioned services.

This year, NICE has made recommendations regarding a number of drugs for first and second line treatment of CML. On 25 April 2012, NICE published final guidance that recommended nilotinib and standard-dose imatinib for first line CML but did not recommend dasatinib. This followed final guidance, published by NICE on 13 January 2012, that recommended nilotinib but did not recommend dasatinib or high-dose imatinib for patients who are resistant or intolerant to standard-dose imatinib.

Both NICE recommendations concerning nilotinib are subject to a patient access scheme agreed between the manufacturer and the Department that reduces the price of the drug.

There is a statutory obligation on the national health service to provide funding for treatments and drugs recommended by NICE technology appraisal guidance within three months of the NICE technology appraisal guidance being published.

Once NICE publishes guidance, health professionals and the organisations that employ them are expected to take it fully into account when deciding what treatments to give people.

However, NICE guidance does not replace the knowledge and skills of individual health professionals who treat patients. If a clinician feels that a certain treatment would be particularly beneficial to a patient, they can recommend it, even if it has not been approved by NICE, subject to the primary care trust (PCT) agreeing to fund the treatment.

The NHS Constitution states that patients have the right to expect local decisions, on the funding of drugs and treatments: “to be made rationally following a proper consideration of the evidence.”

If a PCT decides not to fund a drug, then it should explain that decision.

We will ensure that there are arrangements 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.

From January 2014, under our plans for value-based pricing, we want all patients, including those with CML, to have better access to effective and innovative new drugs at a price that reflects the value they bring to patients and the NHS.

http://www.publications.parliament.uk/pa/cm201213/cmhansrd/cm120903/text/120903w0010.htm#12090429002263

 

Value-Based Pricing causing concern.

This is an excellent news piece written by Ben Adams for InPharm. You can find the original story at the link at the bottom of the page. The Value-Based pricing model is already causing serious concern and with just 18 months until it is implemented much work needs to be done.
Innovation for cancer treatment is already being stifled in the UK by the recent decision of NICE to restrict access to dasatinib. Why should a pharma like BMS invest into a market that won’t invest into life-saving treatment? It is the start of a worrying trend.
I will keep you posted with developments.
Kris

The ABPI has attacked the UK government’s new drug pricing policy, saying it will not benefit the pharma industry.

Value-Based Pricing is set to come into place on 1 January 2014, and will replace the 50-year old PPRS pricing system, which allows pharma to set its own prices and then have its treatments assessed by NICE.

This looks set to change in 18 months’ time, with a new VBP-based system seeing the government set prices for new treatments based on how it values a drug.

As part of this proposal,  NICE’s role in issuing guidance to the NHS will be downgraded.

Value in this context includes whether a drug can ease the burden of illness, has a societal benefit and/or is a step change in innovation.

The ABPI is expected to start negotiations with the government next month, and its chief executive Stephen Whitehead is now publicly setting out his stall.

He said: “Whilst we support a broader definition of value for the assessment of medicines, we are not convinced that value-based pricing will encourage innovation or reward the most effective medicines.

“In fact, we are concerned that value-based pricing could in fact stifle innovation because it will struggle to accurately reflect the inherent gradual and incremental nature of innovation.”

He also said that the ABPI was unclear if VBP will reward the industry enough in order to allow the research and development of new medicines.

“We believe promoting innovation would be better served by developing a pricing scheme that is flexible, holistic, negotiated in a single agreement and which rewards the discovery of new medicines,” he said.

Whitehead added that the issue of patients being able to access medicines should be addressed through the government’s Innovation, Health and Wealth review, something it is currently working on with the Department of Health.

This review was published in December and looks to increase access to medicines and better support the life sciences industry.

Whitehead makes it clear that the ABPI does not want to see the secondary legislation of VBP replace the voluntary PPRS system, but would rather sort out the issues of access with the Department of Health via the IHW.

Ultimately the ABPI wants the PPRS to remain, but would like to see new definitions of value for drugs, with the aim of getting more medicines to patients that have not been deemed cost-effective by NICE.

Open for business 

Whitehead was reacting to the British Prime Minister David Cameron’s speech to the Global Health Summit this week, where he discussed his desire to implement VBP.

The PM was also lauding the success of the life sciences industry, adding that the UK was ‘open for business’ for pharma and biotech companies.

Outside of his VBP discussion, Whitehead said he echoed the Prime Minister’s call to investors that the UK is open for business, and it allowed an opportunity for him to also applaud his members.

“The life sciences industry here is a world leader and this event was a great success,” he said, adding that it is “showcasing to an international audience the pre-eminent science base we have to develop new medicines and life saving treatments.

“The government’s continued support for industry is highly valued and a range of initiatives such as the Patent Box have persuaded companies to research and develop ideas here in the UK,” he concluded.

Comment

The ABPI will now argue that in order to have them stay here, they will ultimately need to drop VBP, or risk a similar situation to Germany, where pharma is protesting against new price controls and barriers to reimbursement.

The government, however, needs to show that it is increasing access to new medicines whilst also getting the best deal – wedded to this is the need to keep the pharma industry in the UK, meaning it will need to make some tough decisions in the coming months.

The negotiations begin in earnest from September – expect more public statements and political manoeuvring from both sides as they come toward a deal.

Ben Adams
http://www.inpharm.com/news/173711/new-uk-drug-pricing-system-will-stifle-innovation

Dasatinib PAS PQ

A Dasatinib PAS (Patient Access Scheme) PQ (Parliamentary Question) has been answered. We have a stock response indicating that it is for the manufacturer to choose to submit a PAS and nothing has yet been submitted to DH (Department of Health) by BMS:

Karl McCartney: To ask the Secretary of State for Health if he will encourage Bristol Myers Squibb to introduce a patient access scheme to discount the price of dasatinib.

Mr Simon Burns: It is for the manufacturers of a drug to decide if they wish to submit a patient access scheme proposal to the Department for potential consideration as part of a National Institute for Health and Clinical Excellence appraisal. The manufacturer of dasatinib has not approached the Department regarding the possibility of a patient access scheme for this drug.

Parliamentary Business – Daily Hansard – Written Answers – 19th April 2012 http://www.publications.parliament.uk/pa/cm201212/cmhansrd/cm120419/text/120419w0001.htm#120419w0001.htm_sbhd43

I urge all readers, again, to write to BMS to introduce a PAS. We know that their line is still ‘exploring all options’, so some more pressure might help them make a decision sooner rather than later.

Thanks,

Kris