Proposal to list nintedanib (Ofev), and remove restrictions from tiotropium bromide (Spiriva)

Medicines

Consultation Closed

What we’re proposing

PHARMAC is seeking feedback on a proposal to list nintedanib (Ofev) and remove the current funding restrictions from tiotropium (Spiriva and Spiriva Respimat)from 1 October 2018, through a provisional agreement with Boehringer Ingelheim NZ Limited.

Nintedanib would be funded, subject to funding restrictions, for the treatment of idiopathic pulmonary fibrosis. Some changes would also be made to the pirfenidone funding restrictions for clarity and to prevent concurrent use of pirfenidone and nintedanib.

A confidential net price reduction for tiotropium would occur in conjunction with the removal of funding restrictions. This change would mean that all funded long-acting muscarinic antagonist (LAMA) monotherapy inhalers would be available without Special Authority restrictions.

Consultation closes at 5 pm on Tuesday 4 September 2018 and feedback can be emailed to andrew.park@pharmac.govt.nz.

What would the effect be?

An additional treatment option would be available for idiopathic pulmonary fibrosis and Special Authority applications would no longer be required for tiotropium. The criteria proposed for nintedanib may allow patients to access funded nintedanib earlier than would be the case under the current criteria in place for pirfenidone.

 

Who we think will be interested

  • Health practitioners and other groups involved in the treatment of respiratory conditions including chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis.
  • Hospital and community pharmacists, DHBs, suppliers and wholesalers.

About nintedanib and tiotropium

Nintedanib

Nintedanib is an antifibrotic indicated for the treatment of IPF. Information regarding nintedanib dosing and administration can be found on the Medsafe datasheet.(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) reviewed a funding application for nintedanib for the treatment of idiopathic pulmonary fibrosis at its meeting in August 2016. The Committee recommended that nintedanib be funded if cost-neutral to pirfenidone. The proposed Special Authority criteria for nintedanib are based upon pirfenidone’s,with changes to prevent concurrent use and to more closely align the diagnosis criterion with current practice (as recommended by the Respiratory Subcommittee of PTAC).

More information, including a link to the PTAC and Subcommittee minutes, can be found in the Application Tracker records for nintedanib.

Tiotropium

Tiotropium is a LAMA indicated for the long term once daily maintenance treatment of bronchospasm and dyspnoea associated COPD, including chronic bronchitis and emphysema. Information regarding tiotropium dosing and administration can be found on the Medsafe datasheets for Spiriva(external link) and Spiriva Respimat(external link).

During the year ending 30 June 2018, there were over 2,500 initial and 6,000 renewal Special Authority applications for tiotropium. If this proposal is progressed, these applications would no longer be required to obtain a full subsidy..

Why we’re proposing this

The funding of nintedanib would provide an alternative treatment option for patients with idiopathic pulmonary fibrosis. The Respiratory Subcommittee has advised that patients who are intolerant of pirfenidone may benefit by switching to nintedanib. The Subcommittee also advised that there is insufficient evidence of benefit from using nintedanib and pirfenidone together or changing the treatment to the other option after a patient’s idiopathic pulmonary fibrosis has progressed (worsened) on treatment. The intention of the Special Authority changes reflect this recommended place in therapy. 

The removal of funding restrictions for tiotropium bromide, in conjunction with a net confidential price reduction, would reduce the burden on prescribers and improve access to this product.

Details about the our proposal

Nintedanib

  • Nintedanib 100 mg and 150 mg liquid filled capsules (Ofev) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule under the subheading Antifibrotics in the Respiratory System and Allergies therapeutic group from 1 October 2018 at the following price and subsidy (ex-manufacturer, excluding GST):
Chemical Presentation Brand Pack size Price and subsidy
Nintedanib Cap 100 mg Ofev 60 OP $2,554.00
Nintedanib Cap 150 mg Ofev 60 OP $3,870.00
  • Ofev would be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:

Special Authority for Subsidy

Initial application - (idiopathic pulmonary fibrosis) only from a respiratory specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

Renewal – (idiopathic pulmonary fibrosis) only from a respiratory specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. Treatment remains clinically appropriate and patient is benefitting from and tolerating treatment; and
  2. Nintedanib is not to be used in combination with pirfenidone; and
  3. Nintedanib is to be discontinued at disease progression (See Note).

Note: disease progression is defined as a decline in percent predicted FVC of 10% or more within any 12 month period.

  • The same restrictions for Ofev would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicines List; HML).
  • A Schedule rule that nintedanib treatment will not be subsidised if patient is also receiving treatment with subsidised pirfenadone would be included.
  • The proposed nintedanib funding restrictions include a criterion that the patient has a forced vital capacity between 50% and 90% predicted. This may allow patients to access funded nintedanib earlier than the criteria in place for pirfenidone which specify a forced vital capacity between 50% and 80% predicted. PHARMAC seeks feedback on the impact of this wider access.
  • Ofev would have subsidy and delisting protection until 28 February 2021.

Pirfenidone

  • The Special Authority criteria for pirfenidone (Esbriet) cap 267 mg in Section B of the Pharmaceutical Schedule would be amended as follows (changes in bold and strikethrough):

Special Authority for Subsidy

Initial application – (idiopathic pulmonary fibrosis) only from a respiratory specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

Renewal – (idiopathic pulmonary fibrosis) only from a respiratory specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following Both:

  1. Treatment remains clinically appropriate and patient is benefitting from and tolerating treatment; and
  2. Pirfenidone is not to be used in combination with nintedanib; and
  3. Pirfenidone is to be discontinued at disease progression (See Note).

Note: disease progression is defined as a decline in percent predicted FVC of 10% or more within any 12 month period.

  • The same restrictions for Esbriet would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicines List; HML).
  • A Schedule rule that pirfenidone treatment will not be subsidised if patient is also receiving treatment with subsidised nintedanib would be included.
  • Note that the proposed amendments to the pirfenidone funding restrictions do not include a change to the forced vital capacity criterion. PHARMAC may consider making a change to this criterion to align with the proposed restrictions for nintedanib in the future, subject to an acceptable agreement being reached with the supplier (Roche).

Tiotropium

  • The list price and subsidy of tiotropium bromide powder and solution for inhalation (Spiriva and Spiriva Respimat) in Section B and Part II of Section H of the Pharmaceutical Schedule would not change, but the Special Authority criteria (as below) in Section B of the Pharmaceutical Schedule would be removed.

Special Authority for Subsidy

Initial application only from a general practitioner or relevant specialist. Approvals valid for 2 years for applications meeting the following criteria:

All of the following:

  1. To be used for the long-term maintenance treatment of bronchospasm and dyspnoea associated with COPD; and
  2. In addition to standard treatment, the patient has trialled a short acting bronchodilator dose of at least 40 µg ipratropium q.i.d for one month; and
  3. Either:

The patient's breathlessness according to the Medical Research Council (UK) dyspnoea scale is:

3.1 Grade 3 (stops for breath after walking about 100 meters or after a few minutes on the level); or
3.2 Grade 4 (too breathless to leave the house, or breathless when dressing or undressing); and

  1. All of the following:

Applicant must state recent measurement of

4.1 Actual FEV1 (litres); and
4.2 Predicted FEV1 (litres); and
4.3 Actual FEV1 as a % of predicted (must be below 60%); and

  1. Either

5.1  Patient is not a smoker (for reporting purposes only); or
5.2  Patient is a smoker and has been offered smoking cessation counselling; and

  1. The patient has been offered annual influenza immunisation.

Renewal only from a general practitioner or relevant specialist. Approvals valid for 2 years for applications meeting the following criteria:

  1. Patient is compliant with the medication; and
  2. Patient has experienced improved COPD symptom control (prescriber determined)
  • The hospital restrictions for Spiriva and Spiriva Respimat in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicines List; HML) would also be removed.
  • The Schedule rule that tiotropium treatment will not be subsidised if patient is also receiving treatment with subsidised inhaled glycopyrronium or umeclidinium would remain.
  • A new confidential rebate would apply to Spiriva and Spiriva Respimat which would reduce the net price to the Funder.

To provide feedback

Send us an email: andrew.park@pharmac.govt.nz by 5pm on 4 September 2018.

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.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our 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.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us 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.