OIA response: Pembrolizumab and nivolumab

Response to a request for information on funded PD-1 inhibitors (pembrolizumab and nivolumab).

25 November 2019

[name and contact details redacted]

Dear [name redacted]

REQUEST FOR INFORMATION

Thank you for your request dated 30 October 2019 under the Official Information Act 1982 (OIA) for information relating to pembrolizumab and nivolumab.  Your request was:

PD-1 indication

Epidemiological Data / Patient Number Assumptions

First-line non small cell lung cancer

  • NSCLC epidemiology in New Zealand
  • PHARMAC assessment of annual patient numbers likely to be treated in 1L – both as a bolus in the first year and annually

Second-line non small cell lung cancer

  • NSCLC epidemiology in New Zealand
  • PHARMAC assessment of annual patient numbers likely to be treated in 2L – both as a bolus in the first year and annually

First-line melanoma

Note: As this indication is already listed on the Pharmaceutical Schedule, it would be useful for us to understand:

  1.  The number of new initiations per month for this indication. The latest available data was via an OIA request, where only data for November and December 2018 was provided. This information over the most recent 12 months would be useful. And
  2. The total number of patients in New Zealand treated with PD-1 inhibitors annually since being reimbursed

Adjuvant melanoma

  • NSCLC epidemiology in New Zealand
  • PHARMAC assessment of annual patient numbers likely to be treated in aMEL – both as a bolus in the first year and annually

Renal cell carcinoma

  • NSCLC epidemiology in New Zealand
  • PHARMAC assessment of annual patient numbers treated for RCC - both 1L & 2L

First-line non-small cell lung cancer (NSCLC)

PHARMAC estimates approximately 1200 patients a year would be eligible for first-line metastatic NSCLC.

This estimate of the size of the patient population does not include consideration of histology, mutation status and PD-1 status. The various Special Authority criteria proposed by our clinical advisors specify that patients must be treatment naïve for metastatic disease, therefore only newly diagnosed patients would be eligible.

We consider there is unlikely to be a significant group of prevalent metastatic NSCLC patients who have not yet received any treatment for their metastatic disease.

Second-line non-small cell lung cancer

PHARMAC estimates there would be 600-800 eligible second-line NSCLC patients a year acknowledging there is significant uncertainty in this estimate.

This estimate of the size of the patient population does not include consideration of histology, mutation status and PD-1 status. Also note, due to the short natural history of the disease we do not expect a significant prevalent population who have received previous first-line treatment for their metastatic disease. 

First-line melanoma

New Special Authority initiations per month, financial year 2018-19 (source, Pharmhouse)

Month

New patients

Total patients

July 2018

24

233

August 2018

25

253

September 2018

30

269

October 2018

25

267

November 2018

27

272

December 2018

19

262

January 2019

24

266

February 2019

29

284

March 2019

30

297

April 2019

21

298

May 2019

34

310

June 2019

28

316

Total annual patient numbers, PD-1 inhibitors.

Year

Number of patients

2016/17

361

2017/18

432

2018/19

545

Adjuvant melanoma

An application for funding of pembrolizumab for an adjuvant treatment for resected Stage III melanoma was received in February 2019. Clinical advice has been sought from PTAC in August 2019 and the Cancer Treatments Subcommittee (CaTSoP) in October 2019. Details of this application can be found on our Application Tracker at https://connect.pharmac.govt.nz/apptracker/s/application-public/a0R2P000000Lw3f(external link)

While we have not yet undertaken economic assessment of this application, our clinical advice indicates the following regarding patient numbers (PTAC minutes (minute 7.33):

“The Committee noted the supplier estimate of approximately 334 patients being suitable for this treatment in the first year (due to a backlog), with fewer patients in subsequent years. The Committee considered this estimate could be too high, however, noting the potential for increased referral from plastic surgery and dermatology services if pembrolizumab were to be funded in this setting. The Committee considered that CaTSoP or Oncology Societies in New Zealand may be able to better estimate patient number”.

Renal cell carcinoma (RCC)

PHARMAC staff have not yet assessed patient numbers for PD-1 inhibitors in a first-line setting for advanced renal cell carcinoma. The number of patients receiving currently funded first-line treatment for RCC (either sunitinib or pazopanib) is approximately 520 patients a year.

Recent PHARMAC analysis of the second-line RCC population has assumed a patient population of 420 patients a year would be eligible for PD-1 inhibitors in this setting following progression on either pazopanib or sunitinib.

We are aware these estimates have considerable uncertainty, however we are in the process of updating them.

PHARMAC approaches its assessment of requests for information under the OIA on the basis that, once released, the information becomes publicly available - in other words once we release the information to you it becomes available to any other party in that exact form (whether by you distributing it to others or by virtue of us receiving the same request from a different third party). 

We trust that this information answers your queries.  We are making our information more freely available, so we will now publish selected OIA responses (excluding personal details) on our website.  Please get in touch with us if you have any questions about this.

Yours sincerely

Alison Hill
Director, Engagement and Implementation