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Cancer Services

Dáil Éireann Debate, Tuesday - 30 June 2020

Tuesday, 30 June 2020

Questions (555)

Cathal Crowe

Question:

555. Deputy Cathal Crowe asked the Minister for Health if the criteria will be revised for funded access to pembrolizumab in view of the fact that many of those diagnosed with cancer have been medically advised to access the drug are being informed they are unable to do so due to the stage of their illness [13600/20]

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Written answers

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.    

Section 19 (4) of the Health (Pricing and Supply of Medical Goods) Act 2013 prohibits the HSE from making a relevant decision except in accordance with the criteria specified in Schedule 3 of the Act.  In that respect the HSE is required to have regard to the following criteria:  

1. the health needs of the public

2. the cost effectiveness of meeting health needs by supplying the item concerned rather than providing other health services,

3. the availability and suitability of items for supply or reimbursement, or both, under Section 59 of the [Health] Act of 1970,

4. the proposed costs, benefits and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks,

5. the potential or actual budget impact of the item or listed item,

6. the clinical need for the item or listed item,

7. the appropriate level of clinical supervision required in relation to the item to ensure patient safety,

8. the efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies) and,

9. the resources available to the Executive.

In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.  Marketing authorisations specify the particular formulation, the route of administration, the dosage, the indications for use, any contraindications, detailed warnings and information on the known safety profile, including adverse reactions associated with use of the product. The conditions of the marketing authorisation are laid down in the Summary of Product Characteristics (SmPC) which accompanies and forms part of the marketing authorisation.  

Pembrolizumab has been granted marketing authorisation for a number of indications and is included on the HSE reimbursement list for some of those indications. In addition, a number of other indications are currently being assessed for reimbursement.

As the Deputy will be aware, the Government decision of 11 May 2018 put in place a package of support measures for the women and families affected by the issues related to CervicalCheck.  Those measures included medicines which might not be approved for reimbursement including Pembrolizumab, once they are prescribed by the treating clinician.

The establishment of such a comprehensive support package reflected the impact of the lack of disclosure of the result of clinical audit and the ensuing controversy on individual women and their families. 

Following that decision, concerns were raised regarding the provision of Pembrolizumab to other cervical cancer patients on the same basis as encompassed by the Government decision of 11 May 2018.  In the light of those concerns, following discussions between the Department and the HSE, the HSE has put in place arrangements, on an exceptional basis, to facilitate access to Pembrolizumab for cervical cancer patients on a case-by-case basis in public hospitals, when a treating clinician determines that this is in the patient’s best interests. It is important to note that all prescribing decisions will be entirely a matter for the treating clinician, in line with patient safety protocols and the Medical Council Guide to Professional Conduct and Ethics.

Clinical trials for various immunotherapies, including pembrolizumab, are ongoing globally for a range of other possible indications which may receive marketing authorisation in the EU over the next number of years. Each of those indications will be considered for reimbursement as market authorisations are granted and applications received.

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