The decision by the HSE not to fund Lu-PSMA-617 illustrates the friction between access and affordability for new cancer treatments. Paul Mulholland reports
At the IMO AGM in April, the Clinical Director of the National Centre for Pharmacoeconomics (NCPE) Prof Michael Barry delivered a talk on drug access. In his presentation, Prof Barry said medications for cancers and rare diseases accounted for approximately two-thirds of all those assessed and reimbursed. However, Prof Barry noted these drugs are usually expensive treatments and rarely prove cost-effective.
Recent documents obtained by the Medical Independent (MI) regarding the assessment of the prostate cancer medication Lu-PSMA-617 (Pluvicto) highlight some of the tensions with the reimbursement process.
On 9 January 2023, the HSE received an application for pricing/reimbursement of Lu-PSMA-617. It is a radioligand therapy for the treatment of adult patients with progressive prostate-specific membrane (PSMA)-antigen positive metastatic castration-resistant prostate cancer. According to the results of the phase 3 VISION trial, Lu-PSMA-617 prolonged imaging-based progression-free survival and overall survival when added to standard care in relevant patients.
Health technology assessment
The HSE commissioned a rapid review process on 10 February 2023. Following receipt of a rapid review dossier, the NCPE advised the HSE on 1 March 2023 that a full health technology assessment (HTA) was required.
The Executive commissioned the HTA, in line with the agreed processes, and the final assessment was received on 12 August 2024. The HTA recommended that Lu-PSMA-617 not be considered for reimbursement.
The matter then progressed to the HSE drugs group, which is the national committee that makes recommendations on the pricing and reimbursement of medicines.
Lu-PSMA-617 was considered at a meeting of the group in April 2025.
It recommended against reimbursement as the group believed the therapy did not represent optimal use of limited HSE resources. The drugs group recommendation was subsequently submitted to the HSE senior leadership team (SLT) for consideration.
Letter
A significant number of consultants were dismayed by the drugs group’s decision. A letter, signed by almost 40 specialists in radiation oncology, medical oncology, radiology, and nuclear medicine, was sent to the HSE CEO Mr Bernard Gloster on 30 April calling for the matter to be reconsidered. Four of these specialists are members of a National Cancer Control Programme (NCCP) working group examining the resources needed to expand radioligand therapy services across Ireland.
The letter pointed out that Lu-PSMA-617 is the last line of therapy for many men with advanced metastatic prostate cancer who have progressed through hormonal therapy and chemotherapy without other therapeutic options. This includes those who are not candidates for PARP inhibitors, Radium-223, or anti-cancer vaccine therapies.
“Clinicians worldwide involved in caring for these patients regard it as a significant breakthrough therapy for patients with advanced disease,” according to the letter.
“It offers the potential to prolong life, delay disease progression, and improve or maintain quality-of-life even in patients with very advanced disease. In many countries, it is already considered standard of care treatment in these patients. The alternative for these men is often best supportive care without any further active anti-cancer therapy.”
The letter stated another radioligand therapy, 177Lu-Dotatate, is currently licensed and reimbursed in Ireland. The therapy is being delivered at St Vincent’s University Hospital, Dublin, for patients with neuroendocrine tumours.
“This therapy is comparable to Pluvicto in terms of its mode of action, including the selection of patients through targeted molecular imaging and the systemic delivery of radionuclides to sites of disease, as well as its cost and cost-effectiveness,” according to the letter.
The letter argued the drugs group recommendation deepened the existing inequitable access to care for cancer patients in Ireland.
“This situation creates a two-tiered system, in which only those with sufficient financial means can access this potentially life-prolonging treatment. We strongly believe that all appropriate patients, regardless of financial status, personal circumstances, or social class, should have equal access to this therapy.”
The letter added there is no treatment abroad option available for Irish public patients to access the therapy.
“In addition, the recommendation against reimbursement… is not in keeping with the stated aim of the Sláintecare programme…. Specifically, it goes against many of the key principles… which include pledges to: Provide universal access to care; ensure timely access to services; and ensure financial protection for patients. The Government should ensure public funding is in place to make this treatment accessible to all eligible patients.”
The letter highlighted that the therapy is already reimbursed by public health systems in several European countries, including France, Italy, Belgium, Switzerland, Austria, the Czech Republic, Slovenia, and Greece for men with advanced metastatic prostate cancer. In the Netherlands, it is available through an early access programme, with individual patient authorisation granted on a case-by-case basis. The therapy is also widely used in the US, Australia, and Israel, among other countries, under its current licensed indication.
Additionally, the letter noted that in the US, the Food and Drug Administration recently expanded Lu-PSMA-617’s approval beyond its prior 2022 last-line use, allowing it to be used before chemotherapy in certain patients.
In requesting that the HSE review the decision, the letter pointed out that the NCCP technology review committee (TRC) voted in favour of reimbursement.
Response
The HSE Chief Clinical Officer Dr Colm Henry wrote to Mr Gloster about the letter on 30 April. Dr Henry said he consulted with Prof Barry on the matter and forwarded the NCPE Clinical Director’s comments to Mr Gloster.
In his assessment, Prof Barry explained the drugs group came to its conclusion based on limitations associated with the clinical evidence supporting the application. These limitations included the “high withdrawal rate” in the VISION trial and the open-label trial design. Prof Barry also noted cabazitaxel was excluded from the standard of care arm of the trial.
“Cabazitaxel is a relevant comparator in the Irish healthcare setting and the drugs group concluded that there was no clear overall survival benefit for Pluvicto as compared with cabazitaxel,” he wrote.
In addition to concerns relating to the clinical evidence, Prof Barry said that the HSE drugs group noted that the “cost-effectiveness estimates far exceeded the conventional willingness to pay thresholds at both list and confidential net prices”.
Prof Barry then responded to the letter’s reference to how the NCCP TRC supported the application, writing “there are a number of issues here”.
First, he explained the NCCP TRC does not make formal reimbursement recommendations to the HSE SLT. Rather its opinion is submitted to the HSE drugs group for consideration.
“In fact, the NCCP TRC acknowledged ‘the lack of comparative evidence with cabazitaxel, a relevant comparator’, and agreed by majority to recommend approval ‘subject to a significant improvement in cost’,” according to Prof Barry.
The NCPE Clinical Director also said the decision against reimbursement was not a matter of equity.
Prof Barry explained that Lu-PSMA-617 is not covered by private health insurers “so it is difficult to see where the equity issue… arises”.
On the availability of the medication in other countries, he argued that such international comparisons were difficult “due to the variation in funding models across jurisdictions”.
Prof Barry added the letter failed to provide information in relation to the systems that are “perhaps closest to Ireland”, in terms of clinical practice. For example, the Scottish Medicines Consortium and the National Institute of Health and Care Excellence in England have not recommended reimbursement under the NHS.
“Therefore, the situation in England and Scotland is similar to Ireland,” he wrote.
In conclusion, Prof Barry said he agreed with the recommendation of the HSE drugs group.
“Of course, the final reimbursement decision rests with the HSE senior leadership team. I would advise the SLT to accept the HSE drugs group recommendation.”
A HSE spokesperson confirmed to MI that the SLT ultimately endorsed the assessment of the drugs group.
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