The highest priority was given to pain relief. Therefore, we urge NHS England to provide clarity on how scores within different categories will be
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- Stella Berry
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1 Yes Don t know Making highly priced drugs of clinical benefit available to the people who need them We agree with the principle of re-evaluating treatments in terms of clinical benefit. While under current practice the Cancer Drugs Fund (CDF) provides access to treatments that are not deemed cost-effective by NICE, clinical benefit should still be considered before a drug can be included on the CDF. The CDF is finite and should only be used to fund those drugs that provide a significant clinical benefit to patients. Increasing the weight given to end of life and quality of life However, we have concerns about the proposed scorecard (appendix D of the proposed Standard Operating Procedures (SOPs) for the CDF), as we believe the scoring system of category 1.B (Overall Survival) is likely to undervalue a treatment that offers extra months of good quality life with loved ones. In a survey we commissioned of 412 people affected by cancer, respondents placed a high value on end of life drugs that can give people approaching the end of their lives precious extra time with friends and family. 98% of respondents indicated that priority should be given to the ability of a drug to extend life (1). Similarly, we feel that the impact of quality of life has been underestimated on the proposed scorecard, as this category only offers a maximum score of three, unlike categories 1.A (Disease Free Survival, Progression Free Survival, Time to Treatment Progression) and 1.B, which each offer a maximum score of % of our survey respondents indicated that priority should also be given to the ability of a drug to improve quality of life. Prostate Cancer UK is a registered charity in England and Wales ( ) and in Scotland (SC039332). A company limited by guarantee registered number (England and Wales).
2 The highest priority was given to pain relief. Therefore, we urge NHS England to provide clarity on how scores within different categories will be weighted and recommend a stronger weighting for end of life drugs and those that provide benefits to quality of life. Collecting data from CDF prescribing We welcome section 9 of the proposed CDF SOPs, Monitoring and audit of the CDF, which outlines the requirement for Area Teams to collect patient outcomes data for the treatments prescribed via the CDF. There are a number of initiatives that are taking UK-based medical research in the direction of real world data reporting. For example, in addition to NHS England s Commissioning through Evaluation (CtE) programme (2), the Health Research Authority (HRA) has launched its HRA Approval project (3), and the Medical and Healthcare products Regulatory Agency (MHRA) is implementing its Early Access to Medicines Scheme (EAMS) (4). At the European level, the European Medicines Agency (EMA) is carrying out pilots for adaptive licensing (5). These initiatives encourage innovation by supporting research and enabling earlier access to treatments for those patients who need them most, which is particularly important for conditions where no alternative or few other treatment options exist. As part of its proposals for a sustainable CDF, we believe that NHS England should secure commitment from NICE to make use of the real world data generated from monitoring and audit of drugs available through the CDF to re-appraise treatments that it has previously not recommended. We urge NHS England to ensure that CDF data is shared with NICE as part of technology appraisals, and as a matter of urgency for any treatments that are de-listed as a result of implementing the proposed SOPs. Patient involvement While we welcome the opportunity to respond to this consultation, we are concerned by the lack of clarity on NHS England s approach to patient engagement as part of its proposed SOPs. Both NICE and the EMA involve patients and patient groups in their drug appraisal processes as critical stakeholders. NICE s approach to patient and public involvement is based on two key principles: that lay people, and organisations representing their interests, have opportunities to contribute to developing NICE guidance, advice and quality standards, and support their implementation, and that, because of this contribution, NICE guidance and other products have a greater focus and relevance for the people most directly affected by NICE recommendations (6). The EMA states that the added value of having patients in benefit-risk discussions is to bring a unique and critical input based on their real-life experience of being affected by a disease and its current therapeutic environment (7). NHS England s approach toward patient involvement is not made clear in the draft CDF SOPs. Furthermore, the proposed meeting formats do not allow for patient engagement, or for a transparent process: the proposed meetings of the National Cancer Drugs Fund (NCDF) panel suggest that decisions will be made behind closed doors, engaging with the pharmaceutical industry only. We strongly recommend that NHS England reviews its proposed approach to patient involvement as part of the CDF decision-making process to ensure patients are able to contribute. We recommend inviting either a patient expert or lay representative to present a summary of the patient experience of a treatment to the NCDF at the proposed open meeting with applicants and other stakeholders (section 9.2 of the draft terms of reference of the NCDF panel).
3 Yes Don t know We acknowledge that the CDF is a finite reserve and therefore we appreciate NHS England s proposed approach of prioritising treatments that deliver the greatest clinical benefit for inclusion on the CDF list, while at the same time seeking a reasonable price from manufacturers for these treatments. However, we are concerned that proposed change (B) will be an unnecessary and less robust duplication of NICE s technology appraisal process, and we are deeply concerned that patients interests are not being prioritised by this proposal. Therefore, we make the following recommendations: Manufacturers should reimburse any overspend of the CDF budget. A Pharmaceutical Price Regulation Scheme (PPRS) (8) style contract should be drawn up to provide an interim solution to current CDF budget over expenditure. This should be a contract between NHS England and relevant pharmaceutical companies. The contract would require all pharmaceutical companies with treatments on the CDF list to reimburse any overspend of the CDF budget at the end of each financial year. This rebate should appear in NHS England s transparent budget reporting. If proposal (B) is implemented, we strongly recommend that NHS England works with NICE to ensure that any treatments removed from the CDF list are re-appraised by NICE as a matter of urgency, making use of CDF real world data where available. Appraisals and Patient Access Scheme (PAS) negotiations for these treatments would need to be accelerated so that patients are not left without treatment. Yes Don t know In order to establish a sustainable CDF, we accept that drugs that are highly priced in relation to the clinical benefit they provide should be given a lower priority for inclusion on the list. However, we are deeply concerned that there are no interim steps in place to protect access to clinically beneficial, highly priced treatments that are de-listed while pricing negotiations take place. We urge NHS England to consider the recommendations set out above: pharmaceutical companies should share the responsibility of over expenditure of the CDF budget; PASs should be negotiated; and de-listed treatments should be appraised/reappraised by NICE as a matter of urgency with support from NHS England s CDF data. In addition, and as stated in response to proposed change (B), we are concerned that proposed change (C) will be an unnecessary and less robust duplication of NICE s technology appraisal process.
4 Yes Don t know We recommend that pricing arrangements are shared between NHS England, NICE and the Department of Health to ensure the best deal for the NHS and agree that commercial confidentiality should be maintained, to protect markets and support innovation in the UK. As previously stated, we strongly urge NHS England to provide opportunities for patient involvement as part of its revised CDF SOPs. Yes Don t know We strongly urge NHS England to work with the pharmaceutical industry, NICE and the Department of Health to ensure that clinically beneficial treatments reach NHS patients. As stated above, we recommend that price adjustments are shared between these bodies to ensure the best deal for the NHS and agree that adjustments should be appropriate and confidential so that markets can be maintained and innovation can be nurtured. We urge NHS England to provide clarity on how price negotiations between the NCDF panel and manufacturers will involve NICE, particularly following a NICE rejection based on cost, as we believe that pricing adjustments will only be appropriate where they are made to achieve the best value for the NHS. We would like to take this opportunity to highlight the difference the CDF has made for men with advanced prostate cancer. Men with advanced prostate cancer living in England currently have access to four life-extending treatments on the CDF: abiraterone, cabazitaxel, enzalutamide, and radium-223 (9). Prostate Cancer UK has collected the views and experiences of men who are receiving abiraterone and enzalutamide via the CDF, or who expect to as part of their optimal treatment pathway: I have had prostate cancer for 3 years it has spread to lymph nodes and liver. I was prescribed abiraterone 6 months ago before chemotherapy and it has made a tremendous difference to my life. I have been able to take up running and swimming again and have been virtually pain free. I just cannot bear to think about what will happen if this drug is denied to me.
5 My prostate cancer has spread to bones etc., so am on Degarelix. When this stops working my best option will be to take either abiraterone or enzalutamide before chemo the thought of up to an extra two years before chemo is needed is wonderful. We would be greatly concerned if any of the options available to men with advanced prostate cancer on the CDF are de-listed as part of the proposed SOPs. Hundreds of men with advanced prostate cancer are currently accessing cabazitaxel, enzalutamide and radium-223 via the CDF, and NHS England currently receives the second highest number of notifications for men to receive abiraterone before chemotherapy (10). Radium-223 and (chemotherapy naïve) enzalutamide are currently funded by the CDF because they have yet to be appraised by NICE. We urge NHS England to ensure that real world data collected by Area Teams according to the proposed CDF SOPs section 9 are provided to NICE as part of the appraisals for these treatments. Both cabazitaxel and (chemotherapy naïve) abiraterone are currently funded by the CDF because, although proven to provide clinical benefit to patients, they have not been deemed cost-effective by NICE. With fewer treatments for advanced prostate cancer being approved for routine use on the NHS by NICE, we urge NHS England to ensure that men can continue to benefit from existing treatment options while sustainable solutions are developed for the CDF. We strongly urge NHS England to build on the success of the CDF and remain accountable for ensuring that NHS patients in England can access their optimum treatment pathway, supporting negotiations for a price that is sustainable for the NHS. We have been made aware that NHS England's Chief Executive, Simon Stevens, has written to the Association of the British Pharmaceutical Industry (ABPI) and NICE, asking them to work together to take Commissioning through Evaluation (CtE) forward. We urge all parties to progress this work to support innovation in the NHS and enable earlier access to treatments for those patients who need them most. We hope that initiatives will be driven by NHS England to lead the reform that the UK drug appraisal system needs to achieve sustainability for the NHS and access to the optimum care for NHS patients. We are concerned that socioeconomic-based health inequalities may arise as a result of de-listing drugs as some people will be in a position to access treatments privately, where others will not. I have been taking abiraterone for the past few months but it no longer works oncologist says enzalutamide is the only alternative but he is not allowed to prescribe it. If I can find 2,700 every month I can buy it privately. I am a pensioner where can I find that money? We would also like to highlight the fact that it is only people living in England that can benefit from the CDF and we would like to see a drugs appraisal system that provides equitable access to treatments across the whole of the UK. For conditions where no alternative or few other treatment options exist, we urge NHS England to apply a greater weighting to innovative drugs for these patient populations when prioritising treatments for inclusion on the CDF list. We recommend that the CDF data collected by Area Teams according to the proposed CDF SOPs (section 9) include age, ethnicity and socioeconomic status data, to ensure that health equality assessments of the CDF can be carried out.
6 1. Prostate Cancer UK. Value-based pricing: Getting it right for people with cancer [Internet] [cited 2013 May 10]. Available from: 2. NHS England» Commissioning through Evaluation [Internet]. [cited 2014 Oct 28]. Available from: 3. Health Research Authority. DH approves HRA business plan to deliver a single approval system for all health research studies in England [Internet] Available from: 4. Medicines and Healthcare products Regulatory Agency. Press Release: Early Access to Medicines Scheme - applications now welcome [Internet]. [cited 2014 Apr 22]. Available from: 5. European Medicines Agency - News and Events - European Medicines Agency launches adaptive licensing pilot project [Internet]. [cited 2014 Oct 21]. Available from: p&mid=wc0b01ac058004d5c1 6. NICE. Patient and Public Involvement Policy [Internet] Available from: 7. European Medicines Agency. Incorporating patients views during evaluation of benefit-risk by the EMA Scientific Committees [Internet] Available from: 8. The Pharmaceutical Price Regulation Scheme Pharmaceutical_Price_Regulation.pdf [Internet]. [cited 2014 Apr 22]. Available from: Regulation.pdf 9. NHS England. National Cancer Drugs Fund List [Internet] Available from: NHS England. Cancer Drug Fund reporting template: Reporting period April June 2014 [Internet] Available from:
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