Decision to change funding restrictions for amino acid infant formula

Medicines

Decision

PHARMAC has made a decision to make changes to the criteria for funding of amino acid infant formula (AAF) from 1 July 2020.

AAF (brand names Alfamino Junior, Elecare and Neocate) is used as a milk substitute in infants who have an allergy or severe intolerance to cow’s milk and cannot take other funded milk substitutes.

AAF is currently funded subject to Special Authority restrictions.

In summary these changes will mean:

  • the existing Special Authority will be replaced with a new form that includes two different sets of funding criteria for:
    • infants up to 12 months of age; and
    • children 12 months of age and over
  • applications for children 12 months of age and over will need to be made by a paediatrician or dietitian on the recommendation of a paediatrician. Paediatricians include paediatric gastroenterologists and paediatric immunologists
  • applications for infants under 12 months of age will be able to be made by any relevant practitioner; this includes relevant specialists, general practitioners with or without vocational registration, dietitians and nurse practitioners.

The following changes will affect both age groups:

  • access criteria will include patients with ultra-short gut and severe immune deficiency
  • access criteria will require the following information:
    • whether the patient’s cow’s milk protein allergy/intolerance is IgE mediated or non-IgE mediated;
    • that AAF is required for a nutritional deficiency;
    • that there has been a period of three months since the previous application for AAF; and
    • in cases where extensively hydrolysed formula (eHF) has previously been trialled:
      • there is a valid Special Authority number for eHF; or
      • the trial has occurred in an inpatient setting.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 16 July 2019

Two changes to the funding criteria were made from the original proposal:

  • The prescriber group for patients under 12 months of age has been changed to ‘any relevant practitioner’. This will include nurse practitioners and general practitioners without a vocational registration.
  • Dietitians, with a recommendation from a paediatrician, have been included in the prescriber group that is able to apply for patients over 12 months of age.

We want to thank everyone who provided feedback to this consultation.

Who we think will be most interested

  • Caregivers and whānau of children prescribed treatment for cow’s milk protein allergy (CMPA).
  • Clinicians who manage treatment of CMPA, including general practitioners, dietitians, paediatricians, paediatric gastroenterologists and paediatric immunologists.
  • Community and hospital pharmacies and pharmacists.
  • Suppliers and wholesalers.
  • Ministry of Health.

Details about this decision

From 1 July 2020, the Special Authority criteria for amino acid formula powder in Section D of the Pharmaceutical Schedule would be replaced as follows (deletion of existing criteria shown in strikethrough and proposed new criteria shown in bold):

Special Authority for Subsidy

Initial application only from a dietitian, relevant specialist or vocationally registered general practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Any of the following:

1        Extensively hydrolysed formula has been reasonably trialled and is inappropriate due to documented severe intolerance or allergy or malabsorption; or

2        History of anaphylaxis to cows milk protein formula or dairy products; or

3        Eosinophilic oesophagitis.

Note: A reasonable trial is defined as a 2-4 week trial.

Renewal only from a dietitian, relevant specialist, vocationally registered general practitioner or general practitioner on the

recommendation of a dietitian, relevant specialist or vocationally registered general practitioner. Approvals valid for 6 months for

applications meeting the following criteria:

All of the following:

1 An assessment as to whether the infant can be transitioned to a cows milk protein, soy, or extensively hydrolysed infant formula has been undertaken; and

2 The outcome of the assessment is that the infant continues to require an amino acid infant formula; and

3 General Practitioners must include the name of the dietitian, relevant specialist or vocationally registered general practitioner and date contacted.


New community Special Authority for Subsidy as of 1 July 2020 as follows:

Special Authority for Subsidy

Initial application - (Infants under 12 months of age) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

1.  Any of the following:

1.1.    History of anaphylaxis to cow’s milk protein formula or dairy products; or
1.2.    Eosinophilic oesophagitis; or
1.3.    Ultra-short gut; or
1.4.    Severe Immune deficiency; or
1.5.    Extensively hydrolysed formula has been trialled in an inpatient setting and is clinically inappropriate; or
1.6.    Both:

1.6.1.  Extensively hydrolysed formula has been reasonably trialled for 2-4 weeks and is inappropriate due to documented severe intolerance or allergy or malabsorption; and
1.6.2.  Either:

1.6.2.1.  The patient has a valid Special Authority approval for extensively hydrolysed formula: approval number; or
1.6.2.2.  Patient has IgE mediated allergy.

Initial application - (Children 12 months of age and over) only from a paediatrician, paediatric gastroenterologist or paediatric immunologist, or a dietitian on the recommendation of a paediatrician, paediatric gastroenterologist or paediatric immunologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

1.   Either:

1.1.    Applicant is a paediatrician, paediatric gastroenterologist or paediatric immunologist; or
1.2.    Applicant is a dietitian and confirms that a paediatrician, paediatric gastroenterologist or paediatric immunologist has been consulted within the last 12 months and has recommended treatment for the patient; and

2.  Any of the following:

2.1.    History of anaphylaxis to cow’s milk protein formula or dairy products; or
2.2.    Eosinophilic oesophagitis; or
2.3.    Ultra-short gut; or
2.4.    Severe Immune deficiency; or
2.5.    Extensively hydrolysed formula has been trialled in an inpatient setting and is clinically inappropriate; or
2.6.    Both:

2.6.1.  Extensively hydrolysed formula has been reasonably trialled for 2-4 weeks and is inappropriate due to documented severe intolerance or allergy or malabsorption; and
2.6.2.  Either:

2.6.2.1.  The patient has a valid Special Authority approval for extensively hydrolysed formula: approval number; or
2.6.2.2.  Patient has IgE mediated allergy.

Renewal - (Infants up to 12 months of age) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Either:

1.      Patient has IgE mediated allergy; and

1.1.    All of the following:

1.1.1.  Patient remains allergic to cow’s milk; and
1.1.2.  An assessment as to whether the infant can be transitioned to a cow’s milk protein, soy or extensively hydrolysed infant formula has been undertaken; and
1.1.3.  The outcome of the assessment is that the infant continues to require an amino acid infant formula; and
1.1.4.  Amino acid formula is required for a nutritional deficit; and
1.1.5.  It has been more than three months from the previous approval; or

2.  Patient has non IgE mediated severe gastrointestinal intolerance (including eosinophilic oesophagitis, ultra-short gut and severe immune deficiency); and

2.1.    All of the following:

2.1.1.  An assessment as to whether the infant can be transitioned to a cow’s milk protein, soy, or extensively hydrolysed infant formula has been undertaken; and
2.1.2.  The outcome of the assessment is that the infant continues to require an amino acid infant formula; and
2.1.3.  Amino acid formula is required for a nutritional deficit; and
2.1.4.  It has been more than three months from the previous approval.

Renewal - (Children 12 months of age and over) only from a paediatrician, paediatric gastroenterologist or paediatric immunologist, or a dietitian on the recommendation of a paediatrician, paediatric gastroenterologist or paediatric immunologist. Approvals valid for 6 months for applications meeting the following criteria:

Both:

1.  Either:

1.1.    Applicant is a paediatrician, paediatric gastroenterologist or paediatric immunologist; or
1.2.    Applicant is a dietitian and confirms that a paediatrician, paediatric gastroenterologist or paediatric immunologist has been consulted within the last 12 months and has recommended treatment for the patient; and

2.  Any of the following:

2.1.    History of anaphylaxis to cow’s milk protein formula or dairy products; or
2.2.    Eosinophilic oesophagitis; or
2.3.    Ultra-short gut; or
2.4.    Severe Immune deficiency; or
2.5.    Extensively hydrolysed formula has been trialled in an inpatient setting and is clinically inappropriate; or
2.6.    Both:

2.6.1.  Extensively hydrolysed formula has been reasonably trialled for 2-4 weeks and is inappropriate due to documented severe intolerance or allergy or malabsorption; and
2.6.2.  Either:

2.6.2.1.  The patient has a valid Special Authority approval for extensively hydrolysed formula: approval number; or
2.6.2.2.  Patient has IgE mediated allergy.

From 1 July 2020, the restriction criteria for amino acid formula powder in Part II of Section H of the Pharmaceutical Schedule will be amended as follows (deletions shown in strikethrough and new criteria shown in bold):

Restricted

Initiation

Any of the following:

  1. Extensively hydrolysed formula has been reasonably trialled for 2-4 weeks and is inappropriate due to documented severe intolerance or allergy or malabsorption; or
  2. History of anaphylaxis to cow’s milk protein formula or dairy products; or
  3. Eosinophilic oesophagitis: or
  4. Ultra-short gut; or
  5. Severe Immune deficiency.

Note: A reasonable trial is defined as a 2-4 week trial.

Continuation

Both All of the following:

  1. An assessment as to whether the infant can be transitioned to a cow’s milk protein, soy, or extensively hydrolysed infant formula has been undertaken; and
  2. The outcome of the assessment is that the infant continues to require an amino acid infant formula; and
  3. Amino acid formula is required for a nutritional deficit.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal and a summary of the main themes raised in feedback, our responses to the feedback received and changes we have made after listening to you are set out below.

Theme

PHARMAC comment

Considered that infants in general practice who pass bloody stools or those with eczema would not be able to be seen by the paediatric department for several months and this could delay treatment.

Following consideration of consultation feedback we have changed the Special Authority for patients under 12 months of age to include a wider group of prescribers. ‘Any relevant practitioner’ includes nurse practitioners and general practitioners without vocational registration. This means that Special Authorities could be applied for in general practice in the situation described.

Concerned that the proposed changes would preclude expert dietitians from submitting applications for amino acid-based formula in patients over 12 months of age. This could lead to delays in appropriate dietary management for children requiring these feeds and put additional stress on secondary care paediatric services.

PHARMAC sought advice from the Special Foods Subcommittee of PTAC regarding dietitian prescribing in this age group. Members of this Subcommittee were supportive of widening access to dietitians if there was a link to paediatric services. The Special Authority has been amended to include dietitians for patients over 12 months of age where they have a recommendation from a paediatrician.

Considered that paediatric clinics in most DHBs would not have the access or capacity to cope with the proposed changes. This may result in infants at 12 month of age attending emergency departments in order to access a prescription under Special Authority. Suggest decision is deferred until disease prevalence is better understood and there is better training and support available for general practice and paediatricians.

Following consideration of consultation feedback and clinical advice we have included dietitians in the Special Authority for patients over 12 months of age where they have had a recommendation from the paediatrician. This will allow DHBs to engage dietitians, in liaison with paediatricians, to manage this patient group.

PHARMAC will make available education materials to support clinicians with this change.

Questioned using an aged-based approach over the assessment of an individual patient given that the Australasian Society of Clinical Immunology and Allergy consider that for some patients CMPA may persist for 3-5 years.

The Special Foods Subcommittee in October 2017 considered whether it would be possible to use criteria other than age. The Subcommittee’s view was that it was not possible to adequately describe the patient that would most benefit from AAF and that, at 12 months of age, children would be transitioning to solids and that those that were more severe CMPA should be under specialist supervision.

Providing education for healthcare professionals on appropriate use would be a preferable approach to manage expenditure on AAF products.  

PHARMAC has previously produced education materials via BPACnz and PHARMAC Seminars on this topic. Our clinical advice supports the new criteria as being the most effective way to ensure that AAF is targeted to children for whom it is most appropriate. We intend to support this change with further education materials for clinicians.

AAF usage could reduce if there was access to an extensively hydrolysed formula with peptides in a very low Dalton size range than currently listed.

PHARMAC recently made a decision to fund an additional extensively hydrolysed formula that has a reduced Dalton size. From 1 November 2019, Allerpro 1 and 2(external link) are funded, subject to restrictions.

Aptamil Gold+ Pepti Junior (extensively hydrolysed) remains funded.

Concern that Special Authorities cannot be held for both extensively hydrolysed formula and AAF.

A Special Authority approval can be held for both extensively hydrolysed formula and AAF at the same time.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.