Proposal relating to the funding of TNF inhibitors (Humira and Enbrel) and gabapentin (Neurontin)

Medicines

Consultation Closed

PHARMAC is seeking feedback on a proposal relating to the funding of the TNF-inhibitor medicines adalimumab (Humira) and etanercept (Enbrel), both used to treat people with various autoimmune and immune-mediated conditions, and gabapentin (Neurontin), used to treat epilepsy and neuropathic pain.

The effect of the proposal would be to make the funding of the TNF-inhibitor treatments and Neurontin more cost-effective and to create savings of more than $20 million over 5 years that would enable PHARMAC to deliver greater health outcomes from available pharmaceutical funding.

PHARMAC welcomes feedback on this proposal by 5pm on Tuesday, 11 August 2015

1. If this proposal goes ahead, would all current patients on adalimumab need to change to etanercept?

No. All patients who are currently receiving funded adalimumab (prior to 1 January 2016) would continue to receive funding for their adalimumab if this remains an appropriate treatment for them and they continue to meet the renewal criteria. They could change to etanercept if their condition does not respond to, or they are intolerant of, adalimumab.

2. If this proposal goes ahead, what if a new patient is started on etanercept and it is not tolerated or doesn’t work?

Adalimumab would still be funded for people as a second-line option where etanercept is not tolerated or has not worked. Patients would need to trial etanercept first before they would be able to access funded adalimumab.

3. If this proposal goes ahead, would a person with Crohn’s disease or fistulising Crohn’s disease need to try etanercept first?

No. People with Crohn’s disease or fistulising Crohn’s disease would still be able to receive funded adalimumab first line. Etanercept is not funded for the treatment of Crohn’s disease or fistulising Crohn’s disease.

4. What clinical advice has PHARMAC received and where can I read this?

PHARMAC received advice from its clinical advisory committee PTAC. The advice is there is no clear clinical reason to prefer one treatment over the other in any of their funded indications other than Crohn’s disease and fistulising Crohn’s disease (for which etanercept is not funded). PTAC considered it would be clinically reasonable for etanercept to be the mandated first-line funded TNF-alpha inhibitor for all new patients. You can find the minutes from their meeting on the PTAC minutes page of PHARMAC's website.

Summary of proposal

In summary the proposal is to:

  • amend the Special Authority criteria and hospital restrictions applying to all presentations of adalimumab (Humira and HumiraPen) listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 January 2016 to make etanercept the first-line funded TNF inhibitor medicine for new rheumatology and dermatology patients, and
  • through a provisional agreement with Pfizer New Zealand Limited:
    • reduce the list prices, subsidies and net costs of all presentations of etanercept (Enbrel) listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 October 2015, and
    • from 1 November 2015:
      • reduce the list prices and subsidies of gabapentin 100 mg, 300 mg and 400 mg capsules (Neurontin) listed in Section B of the Pharmaceutical Schedule
      • amend the Special Authority applying to gabapentin 100 mg, 300 mg and 400 mg capsules (Neurontin) in Section B of the Pharmaceutical Schedule
      • list gabapentin 100 mg, 300 mg and 400 mg capsules (Neurontin) in Part II of Section H of the Pharmaceutical Schedule, and
      • delist gabapentin 600 mg tablets (Neurontin) from Section B and Part II of Section H of the Pharmaceutical Schedule.

Summary of the impact of the proposal on patients and prescribers

The effect of the proposed changes would be that:

  • From 1 January 2016 adalimumab funding for new rheumatology[1] and dermatology[2] patients would be limited to patients who are intolerant of, or whose disease has not responded to, etanercept. Etanercept would be the first-line funded TNF inhibitor medicine for these patients, with adalimumab funded second-line.
  • There would be no change to the funding of adalimumab for any:
    • current patients using it (for any indication); or
    • new patients who have Crohns or Fistulising Crohns disease.
    All of these patients would continue to have funded access to adalimumab as a first-line TNF inhibitor treatment.
  • The Neurontin brand of gabapentin capsules (100 mg, 300 mg and 400 mg) would be fully funded under the same Special Authority/Hospital Restriction criteria that currently apply to other brands of gabapentin (Arrow-Gabapentin and Nupentin).
  • Patients currently being treated with gabapentin 600 mg tablets (Neurontin) would need to switch to an alternative funded strength of gabapentin from 1 November 2015, for example 2 x 300 mg capsules, to continue to receive funded treatment.

Purpose of consultation

The purpose of this consultation is to seek feedback on the proposal, including any practical, clinical or other issues that PHARMAC should be aware of, before PHARMAC makes a decision on the proposal.

This consultation document contains the following sections:

  1. background to the proposal
  2. details of the proposal, and
  3. how to provide feedback.

1.     Background to the proposal

TNF inhibitor medicines (Enbrel and Humira)

Etanercept (brand name Enbrel, supplied by Pfizer) and adalimumab (brand names Humira and HumiraPen, supplied by AbbVie) are tumour necrosis factor (TNF)-alpha inhibitor medicines, a class of biologic treatments used to treat various autoimmune and immune-mediated conditions including rheumatoid arthritis, psoriatic arthritis and psoriasis. Adalimumab and etanercept are both administered by subcutaneous injection in the community. Dosing across indications can vary, but in general etanercept is administered 50 mg once weekly and adalimumab is administered 40 mg once fortnightly.

Both treatments are approved by Medsafe for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis and juvenile idiopathic arthritis. Etanercept, but not adalimumab, is also indicated for paediatric plaque psoriasis. Adalimumab, but not etanercept, is also indicated for axial spondyloarthritis (similar to ankylosing spondylitis), Crohn’s disease and ulcerative colitis. The contraindications of the two treatments are also similar with the exception that, unlike etanercept, adalimumab is also contraindicated in patients with moderate to severe heart failure.

Adalimumab and etanercept are currently fully funded with similar criteria for patients with rheumatoid arthritis, ankylosing spondylitis, severe chronic plaque psoriasis and psoriatic arthritis, for patients with severe disease that has not adequately benefitted from, or where patients cannot tolerate, at least two other non-biologic community funded DMARDs[3]. Both treatments are also funded for the unregistered indications of adult onset Still’s disease and pyoderma gangrenosum.

Adalimumab, but not etanercept, is also funded for patients with Crohn’s disease and fistulising Crohn’s disease (etanercept is not registered or funded for these indications).

Clinicians and patients currently have the option of making a special authority application for funding for either etanercept or adalimumab as a first line TNF inhibitor medicine, with the option of switching to the other treatment second line if the disease fails to respond to, or the patient is intolerant of, the first line option. This would change under the proposal.

Adalimumab is currently the Combined Pharmaceutical Budget’s highest annual gross expenditure medicine, with etanercept number four. Current gross annual expenditure on both of these treatments is approximately $94 million[4] combined and costs are growing rapidly with 15 percent growth in the last year alone, with around 6,400 patients having received funded adalimumab or etanercept in the last year. TNF inhibitor usage is likely to continue to increase because people are living longer and more uses are being discovered for these treatments.

PHARMAC sought advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) when developing this proposal. PTAC considered that it would be clinically reasonable for etanercept to be the mandated first-line funded TNF inhibitor for all new patients for currently funded indications (excluding Crohn’s disease and fistulising Crohn’s disease for which etanercept is not registered or funded). PTAC recommended PHARMAC progress with the proposal. Minutes can be found on the PHARMAC website.

The proposed changes would enable PHARMAC to make the funding of TNF-inhibitors more cost-effective and would create savings of more than $20 million over 5 years that would enable PHARMAC to deliver greater health outcomes from available pharmaceutical funding.

PHARMAC is aware that this proposal, if implemented, would have an impact on prescribers, new patients and their families. If the proposal was progressed, PHARMAC would work with relevant clinical and patient groups and pharmaceutical suppliers to ensure adequate support and resources would be in place before, during and after any funding changes.

Gabapentin (Neurontin)

There are currently three brands of gabapentin funded on the Pharmaceutical Schedule: Nupentin (supplied by Mylan), Arrow-Gabapentin (supplied by Actavis) and Neurontin (supplied by Pfizer). Nupentin and Arrow-Gabapentin are fully funded for any patient who meets the Special Authority criteria for epilepsy and neuropathic pain or chronic kidney disease associated-pruritus. Neurontin is currently only funded for patients with epilepsy who had an approval for Neurontin prior to 1 August 2009. This funding situation arose from a previous PHARMAC competitive procurement process for the supply of gabapentin.

This proposal would amend the price, subsidy and Special Authority criteria of the Neurontin brand of gabapentin to match that of Nupentin and Arrow-Gabapentin. At the same time, it is also proposed that the 600 mg tablet presentation of Neurontin, which is used by less than <1% of patients, be delisted from the Pharmaceutical Schedule. PHARMAC considers that the very small number of patients currently taking this presentation could be safely switched to an alternative funded strength of gabapentin (eg 2 x 300 mg tablets); however before making a decision on the proposal we are keen to understand if there would be any circumstances where this might not be the case.

2.     Details of the proposal

In relation to etanercept (Enbrel)

  • From 1 October 2015 the prices and subsidies of etanercept (Enbrel) would be reduced in Section B and Part II of Section H of the Pharmaceutical Schedule as follows (all prices are ex-manufacturer and exclude GST):
    Chemical and presentation Brand Pack size Current Price/Subsidy Proposed Price/Subsidy
    Etanercept Inj 25 mg Enbrel 4 $949.96 $799.96
    Etanercept Inj 50 mg autoinjector Enbrel 4 $1,899.92 $1,599.96
    Etanercept Inj 50 mg prefilled syringe Enbrel 4 $1,899.92 $1,599.96
  • Confidential rebates would apply to Enbrel, reducing its net price to the funder and DHB hospitals.
  • Enbrel would remain listed in Section B and Part II of Section H of the Pharmaceutical Schedule subject to its current Special Authority and restrictions. These are detailed in the Pharmaceutical Schedule that can be found on the PHARMAC website.
  • Enbrel would have protection from subsidy reduction, delisting, and Special Authority/ HML restriction changes until 30 June 2019.

In relation to adalimumab (Humira and HumiraPen)

  • From 1 January 2016 the Special Authority criteria applying to all presentations of adalimumab[5] (Humira/HumiraPen) listed in Section B of the Pharmaceutical Schedule would be deleted and replaced with the following (similar hospital restriction changes would also be made in Part II of Section H of the Pharmaceutical Schedule):

Adalimumab

SAXXX Special Authority for Subsidy

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

Both:

Renewal - (rheumatoid arthritis) 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:

Initial application - (Crohn's disease) only from a gastroenterologist. Approvals valid for 3 months for applications meeting the following criteria:

All of the following:

Renewal - (Crohn's disease) only from a gastroenterologist or Practitioner on the recommendation of a gastroenterologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

Initial application - (severe chronic plaque psoriasis) only from a dermatologist. Approvals valid for 4 months for applications meeting the following criteria:

Both:

Renewal - (severe chronic plaque psoriasis) only from a dermatologist or Practitioner on the recommendation of a dermatologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

Note: A treatment course is defined as a minimum of 12 weeks adalimumab treatment.

Initial application - (ankylosing spondylitis) only from a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

Both:

Renewal - (ankylosing spondylitis) 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:

Notes: The BASDAI must have been determined at the completion of the 3 month exercise trial, but prior to ceasing NSAID treatment.. Average normal chest expansion corrected for age and gender:

18-24 years - Male: 7.0 cm; Female: 5.5 cm

25-34 years - Male: 7.5 cm; Female: 5.5 cm

35-44 years - Male: 6.5 cm; Female: 4.5 cm

45-54 years - Male: 6.0 cm; Female: 5.0 cm

55-64 years - Male: 5.5 cm; Female: 4.0 cm

65-74 years - Male: 4.0 cm; Female: 4.0 cm

75+ years - Male: 3.0 cm; Female: 2.5 cm

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

Both:

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:

All of the following:

Initial application - (juvenile idiopathic arthritis) only from a named specialist or rheumatologist. Approvals valid for 4 months for applications meeting the following criteria:

Both:

Renewal - (juvenile idiopathic arthritis) only from a named specialist, rheumatologist or Practitioner on the recommendation of a named specialist or rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

Initial application - (fistulising Crohn’s disease) only from a gastroenterologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

Note
A maximum of 4 months’ adalimumab will be subsidised on an initial Special Authority approval for fistulising Crohn’s disease.

Renewal - (fistulising Crohn’s disease) only from a gastroenterologist or Practitioner on the recommendation of a gastroenterologist. Approvals valid for 6 months for applications meeting the following criteria:

Both:

Initial application - (pyoderma gangrenosum) only from a dermatologist. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

Note

Indications marked with * are Unapproved Indications (refer to (Interpretations and Definitions).

Renewal - (pyoderma gangrenosum) only from a dermatologist or Practitioner on the recommendation of a dermatologist. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

  1. Patient has shown clinical improvement; and
  2. Patient continues to require treatment; and
  3. A maximum of 4 doses.

Initial application - (adult-onset Still's disease) only from a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

Both:

Note

Indications marked with * are Unapproved Indications (refer to (Interpretations and Definitions).

Renewal - (adult-onset Still's disease) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

Both:

  • No changes to the list prices or subsidies for Humira and HumiraPen are proposed. We note that there are confidential rebates for Humira and HumiraPen as a result of PHARMAC’s Agreement with AbbVie which reduce the net price of these products to the funder and DHB Hospitals.

In relation to gabapentin (Neurontin)

  • From 1 November 2015 the prices and subsidies of gabapentin (Neurontin) would be reduced in Section B of the Pharmaceutical Schedule as follows (all prices are ex-manufacturer and exclude GST):
    Chemical and presentation Brand Pack size Current Price/Subsidy Proposed Price/Subsidy
    Gabapentin cap 100 mg Neurontin 100 $13.26 $7.16
    Gabapentin cap 300 mg Neurontin 100 $39.76 $11.00
    Gabapentin cap 400 mg Neurontin 100 $53.01 $13.75
  • Neurontin 100 mg, 300 mg and 400 mg capsules would also be listed in Part II of Section H of the Pharmaceutical Schedule from 1 November 2015 at the above prices (ex-manufacturer, excluding GST).
  • From 1 November 2015 the funding of Neurontin 100 mg, 300 mg and 400 mg capsules would be subject to the same restrictions that currently apply to the Nupentin and Arrow-Gabapentin brands of gabapentin (Special Authority in Section B, prescribing restrictions in Part II of Section H).
  • Neurontin would have protection from subsidy reduction, delisting, and Special Authority/HML restriction changes until 30 June 2016.
  • From 1 November 2015 Neurontin 600 mg tablets would be delisted from Section B and Part II of Section H of the Pharmaceutical Schedule.

3.     How to provide feedback

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5pm on Tuesday, 11 August 2015 to:

Jackie Evans
Senior Therapeutic Group Manager
PHARMAC

Email: tnf@pharmac.govt.nz

Fax:    04 460 4995

Post:   PO Box 10254, Wellington 6143

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

Feedback PHARMAC receives is subject to the Official Information Act 1982 (OIA). PHARMAC will consider any request to have information withheld in accordance with its obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

PHARMAC is not able to treat any part of your feedback as confidential unless you specifically request that it does so, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like PHARMAC to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.


[1] Patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, juvenile idiopathic arthritis and adult-onset still’s disease

[2] Patients with severe chronic plaque psoriasis and pyoderma gengrenosum

[3] disease-modifying antirheumatic drugs, or DMARDs, work by curbing the underlying processes that cause certain forms of inflammatory arthritis including rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. DMARDs include hydroxychloroquine, leflunomide, cyclosporine, sulfasalazine, methotrexate, azathioprine and cyclophosphamide

[4] Both adalimumab and etanercept are currently subject to confidential rebates that reduce the net price to the funder

[5] Current funding criteria can be found in the Pharmaceutical Schedule on our website