Proposal to change access to azithromycin and lamivudine and list roxithromycin dispersible tablets approved

Medicines Decision

PHARMAC is pleased to announce the approval of a proposal relating to changing access to azithromycin and lamivudine and the listing of roxithromycin dispersible tablets to take effect from 1 July 2017.

This was the subject of a consultation letter dated 8 May 2017 and an updated consultation letter dated 12 May 2017.

In summary, the effect of the decision is that:

  • Azithromycin (Apo-Azithromycin, Zithromax) funding criteria will be widened to include the treatment of non-cystic fibrosis bronchiectasis in children.
  • Lamivudine (Zeffix) funding criteria will be widened to include prophylaxis of hepatitis B reinfection in immunocompromised patients receiving rituximab-based treatment for malignancy.
  • Roxithromycin dispersible tablets (Rulide D), through an agreement with Sanofi-Aventis New Zealand Ltd, will be funded for children under 12 years of age. Over 8000 children will benefit from a dispersible form of this antibiotic.

The decision is as consulted on, with the exception of the following:

  • Following consideration of feedback to consultation, ‘Mycobacterium infections’ has been amended to read ‘atypical mycobacterial infections’ to clarify the intent of the Special Authority to exclude tuberculosis and leprosy.
  • In addition, following consideration of feedback to consultation, the Original Pack ‘OP’ rule was added to lamivudine oral liquid 5 mg per ml.

Details of the decision

Azithromycin – for treatment of non-cystic fibrosis bronchiectasis in children

  • Funding criteria for azithromycin 250 mg and 500 mg tablets (Apo-Azithromycin) and granules for oral liquid 200 mg per 5 ml (40 mg per ml) (Zithromax) will be widened in Section B (Community) and in Part II of Section H (Hospital) of the Pharmaceutical Schedule from 1 July 2017 to allow funding of more than 5 days’ treatment in children with non-CF bronchiectasis and people with atypical mycobacterial infections.
  • To effect this change, the current restrictions for azithromycin in Section B of the Pharmaceutical Schedule will be replaced by the following:

AZITHROMYCIN – Maximum of 5 days treatment per prescription; can be waived by endorsement Special Authority

For Endorsement, patient has either:

1. Received a lung transplant and requires treatment or prophylaxis for bronchiolitis obliterans syndrome*; or
2. Cystic fibrosis and has chronic infection with Pseudomonas aeruginosa or Pseudomonas related gram negative organisms*.

Indications marked with * are Unapproved Indications

Special Authority for Waiver of Rule

Initial application – (bronchiolitis obliterans syndrome, cystic fibrosis and atypical Mycobacterialinfections) from any relevant specialist. Approvals valid without further renewal unless notified for applications meeting the following criteria:

Any of the following:

  1. Patient has received a lung transplant and requires treatment or prophylaxis for bronchiolitis obliterans syndrome*; or
  2. Patient has cystic fibrosis and has chronic infection with Pseudomonas aeruginosa or Pseudomonas-related gram negative organisms*; or
  3. Patient has an atypicalmycobacterialinfection.

Indications marked with * are Unapproved Indications

Initial application – (non-cystic fibrosis bronchiectasis*) only from a respiratory specialist or paediatrician. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. For prophylaxis of exacerbations of non-cystic fibrosis bronchiectasis*; and
  2. Patient is aged 18 and under; and
  3. Either:

3.1 Patient has had 3 or more exacerbations of their bronchiectasis, within a 12 month period; or
3.2 Patient has had 3 acute admissions to hospital for treatment of infective respiratory exacerbations within a 12 month period.

Indications marked with * are Unapproved Indications

Renewal – (non-cystic fibrosis bronchiectasis*) only from a respiratory specialist or paediatrician. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. The patient has completed 12 months of azithromycin treatment for non-cystic fibrosis bronchiectasis; and
  2. Following initial 12 months of treatment, the patient has not received any further azithromycin treatment for non-cystic fibrosis bronchiectasis for a further 12 months, unless considered clinically inappropriate to stop treatment; and
  3. The patient will not receive more than a total of 24 months’ azithromycin cumulative treatment (see note).

The patient must have had no more than 1 prior approval.

Note: no further renewals will be subsidised. A maximum of 24 months of azithromycin treatment for non-cystic fibrosis bronchiectasis will be subsidised.

Indications marked with * are Unapproved Indications

  • A similar restriction will apply in Part II of Section H of the Pharmaceutical Schedule from 1 July 2017, as follows: 

Restricted

Initiation – bronchiolitis obliterans syndrome, cystic fibrosis and atypical Mycobacterialinfections

Any of the following:

  1. Patient has received a lung transplant and requires treatment or prophylaxis for bronchiolitis obliterans syndrome*; or
  2. Patient has cystic fibrosis and has chronic infection with Pseudomonas aeruginosa or Pseudomonas-related gram negative organisms*; or
  3. Patient has an atypical MycobacterialinfectionFor any other condition for five days' treatment, with review after five days.

Indications marked with * are Unapproved Indications

Initiation - non-cystic fibrosis bronchiectasis*

Respiratory specialist or paediatrician

Re-assessment required after 12 months

All of the following:

  1. For prophylaxis of exacerbations of non-cystic fibrosis bronchiectasis*; and
  2. Patient is aged 18 and under; and
  3. Either:

3.1 Patient has had 3 or more exacerbations of their bronchiectasis, within a 12 month period; or
3.2 Patient has had 3 acute admissions to hospital for treatment of infective respiratory exacerbations within a 12 month period.

Indications marked with * are Unapproved Indications

Continuation - non-cystic fibrosis bronchiectasis*

Respiratory specialist or paediatrician

Re-assessment required after 12 months

All of the following:

  1. The patient has completed 12 months of azithromycin treatment for non-cystic fibrosis bronchiectasis; and
  2. Following initial 12 months of treatment, the patient has not received any further azithromycin treatment for non-cystic fibrosis bronchiectasis for a further 12 months, unless considered clinically inappropriate to stop treatment; and
  3. The patient will not receive more than a total of 24 months’ azithromycin cumulative treatment (see note).

Note: A maximum of 24 months of azithromycin treatment for non-cystic fibrosis will be subsidised in the community.

Indications marked with * are Unapproved Indications 

Initiation – other indications

Re-assessment required after 5 days

For any other condition.

Continuation – other indications

Re-assessment required after 5 days

For any other condition.

For the avoidance of doubt, there is no change to the maximum of 5 days funded treatment per prescription for any indication which can be waived by Special Authority for certain indications. 

Lamivudine – for prophylaxis of hepatitis B reinfection in immunocompromised patients receiving treatment for malignancy

  • Funding criteria for lamivudine 100 mg tablets and oral liquid 5 mg per ml (Zeffix) will be widened in Section B of the Pharmaceutical Schedule from 1 July 2017 to include prophylaxis of hepatitis B reinfection in immunocompromised patients receiving rituximab in combination with immunosuppressive chemotherapy for malignancy as shown (additions in bold, deletions in strikethrough)

Special Authority for Subsidy

Initial application only from a gastroenterologist, infectious disease specialist, paediatrician, general physician or medical practitioner on the recommendation of a gastroenterologist, infectious disease specialist, paediatrician or general physician. Approvals valid for 1 year for applications meeting the following criteria:

Any of the following:

  1. Hepatitis B virus (HBV) DNA-positive cirrhosis prior to liver transplantation; or
  2. Hepatitis B surface antigen (HBsAg)-positive and has had a liver, kidney, heart, lung or bone marrow transplant; or
  3. Hepatitis B virus naïve patient HBV-naïve patient who has received a liver transplant from a an anti-HBc (H hepatitis B core antibody (anti-HBc)-positive donor; or
  4. Hepatitis B surface antigen HBsAg-positive patient who is receiving chemotherapy for a malignancy, or high dose steroids (at least 20 mg/day for at least 7 days), or who has received such treatment within the previous two months; or
  5. Hepatitis B surface antigen HBsAg-positive patient who is receiving anti-tumour necrosis factor treatment; or
  6. Hepatitis B core antibody (anti-HBc) Anti-HBc-positive patient who is receiving rituximab in combination with immunosuppressive chemotherapies for a malignancy. plus high dose steroids (e.g. R-CHOP)
  • Some minor changes have been made for consistency of language that do not change the intent of the existing criteria.
  • There are no changes the renewal criteria.
  • A similar restriction will apply in Part II of Section H of the Pharmaceutical Schedule from 1 July 2017.
  • The OP rule will be added to the Zeffix brand of lamivudine oral liq 5 mg per ml, 240 ml in Section B of the Pharmaceutical Schedule from 1 July 2017.

Roxithromycin dispersible tablet for children

Roxithromycin (Rulide D) 50 mg dispersible tablet will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 July 2017 at the following price