Proposal to widen access to secukinumab for psoriatic arthritis and ankylosing spondylitis

Medicines Consultation Closed

We are seeking feedback on a proposal to widen access to secukinumab (Cosentyx)

What we’re proposing

We are seeking feedback on a proposal to widen access to secukinumab (Cosentyx) to include the treatment of psoriatic arthritis and ankylosing spondylitis through a provisional agreement with Novartis New Zealand Limited (Novartis).

This proposal would result in the following changes from 1 May 2021:

The agreement with Novartis would also include amendments to the contractual arrangements for fingolimod (Gilenya) and ciclosporin (Neoral). There would be no changes to the funding of these products, but the net price would reduce via a confidential rebate and they would have protection from delisting and subsidy restriction until 31 December 2022.

Further details on this proposal, including how to provide feedback, can be found below.

Consultation closes at 5 pm Monday 22 February 2021 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

From 1 May 2021, funded access to secukinumab would be widened to include patients with psoriatic arthritis or ankylosing spondylitis as described below:

  • psoriatic arthritis: for people who have tried immunosuppressant agents such as methotrexate and sulfasalazine or leflunomide and not received an adequate response; and
  • ankylosing spondylitis: for people who have tried adalimumab and/or etanercept and not received an adequate response.

This would provide an additional line of biological treatment to these patients. We estimate that approximately 200 patients would benefit in the first year increasing to up to 1,000 patients benefitting each year, after five years.  

There would be no change for patients currently using fingolimod or ciclosporin through this proposal. These products would continue to be fully funded.

Who we think will be interested

  • People with psoriatic arthritis or ankylosing spondylitis and their whānau, family, and caregivers
  • Rheumatologists, specialist nurses, general practitioners, dermatologists, and other health professionals involved in the care of people with psoriatic arthritis and ankylosing spondylitis
  • Hospital and community pharmacists, DHBs and wholesalers
  • Pharmaceutical suppliers
  • Other organisations with an interest in rheumatological conditions and treatments

About psoriatic arthritis and ankylosing spondylitis

Psoriatic arthritis

Psoriatic arthritis is a type of inflammatory arthritis that affects some people who have a skin condition called psoriasis. Psoriatic arthritis can cause pain and stiffness in the joints. It can also cause swelling in areas where tendons attach to bones (a condition called enthesitis) and swelling of an entire finger or toe (a condition called dactylitis). Psoriatic arthritis is associated with psoriasis, which causes red, scaly skin patches (also called plaques) and nail abnormalities such as discoloured or brittle nails.

Ankylosing spondylitis

Ankylosing spondylitis is a chronic inflammatory disease which causes progressive, irreversible, structural damage to parts of the skeleton, resulting in back pain and spinal stiffness.

Both psoriatic arthritis and ankylosing spondylitis are chronic conditions; they can last for years or be lifelong.

About secukinumab

Secukinumab

Secukinumab is a recombinant fully human monoclonal antibody that selectively binds interleukin-17A to inhibit its proinflammatory effects.

Secukinumab is currently funded for use in the treatment of severe chronic plaque psoriasis.(external link)

Secukinumab is registered for the treatment of:

  • moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy;
  • adult patients with active psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate; and
  • adult patients with active ankylosing spondylitis.

Secukinumab is given as a 4-weekly subcutaneous injection following initial dosing.

Detailed information about secukinumab dosing and administration can be found in the Medsafe datasheet.(external link)

Why we’re proposing this

A funding application for widened access to secukinumab to include people with psoriatic arthritis and ankylosing spondylitis was reviewed by PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC) in February 2018.(external link)

PTAC recommended that secukinumab be funded with a medium priority:

  • for the treatment of psoriatic arthritis as a first line biologic (alongside adalimumab and etanercept); and
  • for the treatment of ankylosing spondylitis as a second line biologic (after adalimumab or etanercept).

Novartis submitted a commercial proposal involving secukinumab, fingolimod and ciclosporin. We consider that this proposal would provide considerable benefit towards getting the best health outcomes within the funding provided.

Details about our proposal

Secukinumab

Funded access to secukinumab would be amended in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 May 2021 to include people with psoriatic arthritis or ankylosing spondylitis as follows (new criteria shown only):

Special Authority for Subsidy

Initial application — (psoriatic arthritis) only from a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

Either:

  1. Both:
    1. The patient has had an initial Special Authority approval for adalimumab or etanercept for psoriatic arthritis; and
    2. Either: 
      1. The patient has experienced intolerable side effects from adalimumab or etanercept; or
      2. The patient has received insufficient benefit from adalimumab or etanercept to meet the renewal criteria for adalimumab or etanercept for psoriatic arthritis; or
  2. All of the following:
    1. Patient has had severe active psoriatic arthritis for six months duration or longer; and
    2. Patient has tried and not responded to at least three months of oral or parenteral methotrexate at a dose of at least 20 mg weekly or a maximum tolerated dose; and
    3. Patient has tried and not responded to at least three months of sulfasalazine at a dose of at least 2 g per day or leflunomide at a dose of up to 20 mg daily (or maximum tolerated doses); and
    4. Either:
      1. Patient has persistent symptoms of poorly controlled and active disease in at least 15 swollen, tender joints; or
      2. Patient has persistent symptoms of poorly controlled and active disease in at least four joints from the following: wrist, elbow, knee, ankle, and either shoulder or hip; and
    5. Any of the following:
      1. Patient has a C-reactive protein level greater than 15 mg/L measured no more than one month prior to the date of this application; or
      2. Patient has an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or
      3. ESR and CRP not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so for more than three months.

Renewal — (psoriatic arthritis) only from a rheumatologist or practitioner on the recommendation of a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

Both:

  1. Either:
    1. Following 3 to 4 months' initial treatment, the patient has at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
    2. The patient demonstrates at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to prior secukinumab treatment in the opinion of the treating physician; and
  2. Secukinumab to be administered at doses no greater than 300 mg monthly.

Initial application — (ankylosing spondylitis – second-line biologic) only from a rheumatologist or practitioner on the recommendation of a rheumatologist. Approvals valid for 3 months for applications meeting the following criteria:

Both:

  1. The patient has had an initial Special Authority approval for adalimumab and/or etanercept for ankylosing spondylitis; and
  2. Either
    1. The patient has experienced intolerable side effects from a reasonable trial of adalimumab and/or etanercept; or
    2. Following 12 weeks of adalimumab and/or etanercept treatment, the patient did not meet the renewal criteria for adalimumab and/or etanercept for ankylosing spondylitis.

Renewal — (ankylosing spondylitis – second-line biologic) only from a rheumatologist or practitioner on the recommendation of a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. Following 12 weeks initial treatment of secukinumab treatment, BASDAI has improved by 4 or more points from pre-secukinumab baseline on a 10 point scale, or by 50%, whichever is less; and
  2. Physician considers that the patient has benefitted from treatment and that continued treatment is appropriate; and
  3. Secukinumab to be administered at doses no greater than 150 mg monthly.

The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule. There are no proposed changes to other existing Special Authority criteria or hospital restrictions for secukinumab.

Secukinumab inj 150 mg per ml, 1 ml prefilled syringe (1 prefilled syringe pack) would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule, subject to the funding restrictions proposed above, from 1 May 2021 at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical

Formulation

Brand

Pack size

Price and subsidy

Secukinumab

Inj 150 mg per ml, 1 ml

Cosentyx

1

$799.50

A confidential rebate would apply to Novartis’ brand of secukinumab (Cosentyx) that would reduce the net price to the Funder and it would have protection from delisting and subsidy reduction until 30 April 2023.

Other changes associated with this proposal

As part of this proposal, the net price would reduce via confidential rebate and protection from delisting and subsidy reduction until 31 December 2022 would also be provided for the following treatments that are currently supplied by Novartis:

  • Fingolimod (Gilenya) cap 0.5 mg
  • Ciclosporin (Neoral) cap 25 mg, 50 mg and 100 mg, and oral liq 100 mg per ml

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5 pm Monday 22 February 2021.

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Your feedback may be shared

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.

We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.