7 October 2021


Re: The full funding of Caffeine Citrated (Cayona) by the Medical Scheme as a Prescribed Minimum Benefit

We refer to the above matter and several communications received on the 13th of March 2020.

Caffeine Citrated (Cayona) is used for the short-term treatment of apnea of prematurity in infants between 28 and younger than 33 weeks gestational age. It is a bronchial smoot muscle relaxant, a CNS stimulant, a cardiac muscle stimulant and a diuretic.

Cayona is registered and licensed as such with the South African Health Products Regulatory Authority. Furthermore, with regards to compounding medicines Section 14 (4) of the Medicines and Related Substances Act 101 of 1965, state the following:

14. Prohibition on the sale of medicines which are subject to registration and are not registered
(4) The provisions of subsection (1) shall not apply in respect of the sale of any medicine-
(a) compounded in the course of carrying on his or her professional activities by a pharmacist, veterinarian or person who is the holder of a license contemplated in section 22C (1) (a), for a particular patient in a quantity not greater than the quantity required for treatment as determined by the medical practitioner, pharmacist, practitioner, or veterinarian; or
(b) compounded by a pharmacist in a quantity not greater than that prescribed by regulation for sale in the retail trade, subject to the conditions likewise prescribed or in a quantity for a particular person or animal as prescribed by a medical practitioner or a dentist or a veterinarian or a practitioner or a nurse or other person registered under the Health Professions Act, 1974, and referred to in section 22A, as the case may be,

if such medicine does not contain any component the sale of which is prohibited by this Act or any component in respect of which an application for registration has been rejected and is not or has not been advertised: Provided that the active components of such medicine appear in another medicine which has been registered under this Act.

This means that the Medicines and Related Substances Act 101 of 1965, as amended, permits pharmacists to compound medicine in a lifesaving situation, however where there is a formally registered pharmaceutical formulation the superior standard of care must be adhered to. Cayona is a formally registered interchangeable multi-source medicine and the only replacement legally allowed; this does not include caffeine powder reconstituted in a pharmacy. Therefore, there is no need
for a compounded medicine and the product is being used across the country at state hospitals. It is the exception to the rule if a state hospital chooses to compound, see attached Articles marked from 1 to 11).

Apnea is a prescribed minimum benefit and appears as such in the Medical Scheme prescribed minimum benefits regulations.

The prescribed minimum benefit (PMB) regulations prescribed in the Medical Schemes Act cover the diagnosis, treatment and care of the disease. Coverage also includes the diagnosis, treatment and care of any complications that may occur either from the disease itself or from the treatment of the disease.

The Medical Schemes Act (131 of 1998) (“the Act”) introduced a mandatory minimum level of benefits that all benefit options are required to provide – the Prescribed Minimum Benefits (‘PMBs”) – which covers 270 diagnosis-treatment pairs, emergency treatment, and cover for a set of chronic conditions according to the Chronic Disease List. In terms of section 29 of the Act, medical schemes must pay for the diagnosis, treatment, and care costs of these PMBs, in full, without any co-payments or the
use of deductibles.

Regulation 8 of the General Regulations to the Medical Schemes Act (Act 131 of 1998), as amended, requires of a medical scheme to cover the full costs related to the diagnosis, treatment, and care of the PMB conditions.

Regulation 8(1) provides that PMBs must be “funded in full and without co-payment”, however the schemes in this case insists on not funding the required treatment. Schemes rely on its rules and the formulary which provide that the treatment is not funded from the Chronic Illness Benefit for the Members’ plan. Regulation 8 (1) further provides that “…any benefit option that is offered by a medical scheme must pay in full without co-payment or the use of deductibles…” It is clear that
PMB’s must be funded in full no matter what benefit option a member is on; a scheme can therefore not discriminate against members as a result of the option that they are on.

Regulation 8 does allow medical schemes to make funding choices on the basis of the managed care, which invokes the regulations found in chapter 5 under the heading “Provision of Managed Health Care”.

Regulation 8(4) of the Act states that “these regulations must not be construed to prevent medical schemes from employing appropriate interventions aimed at improving the efficiency and effectiveness of health care provisions, including such techniques as requirements for pre-authorisation, the application of treatment protocols, and the use of formularies”.

Regulation 8 (5) states that, “when a formulary includes a drug that is clinically appropriate and effective for the treatment of a prescribed minimum benefit condition suffered by a beneficiary, and that beneficiary knowingly declines the formulary drug and opts to use another drug instead, the scheme may impose a co-payment on the relevant member.” Clinical appropriateness is an important factor that the Scheme should consider in making a funding decision on Cayona herein.

In terms of Regulation 15D, if a scheme employs managed health care as an “appropriate intervention” in terms of regulation 8(4), the scheme must ensure that a written protocol is in place that describes all utilisation review activities, including, inter alia , a description of the procedures to evaluate the clinical necessity, appropriateness, efficiency and affordability of relevant health services, and to intervene where necessary, as well as the methods to inform beneficiaries and health care providers acting on their behalf, as well as the medical scheme trustees, of the outcome of these procedures.

Regulation 15H(c) of the medical schemes act reads as follows:
“Protocols- if managed health care entails the use of a protocol-
(a) such protocol must be developed on the basis of evidence-based medicine, taking into account
considerations of cost-effectiveness and affordability.
(b) the medical scheme and the managed health care organization must provide such protocol to health care providers, beneficiaries, and members of the public upon request; and
(c) provision must be made for appropriate exceptions where a protocol has been ineffective or causes
or would cause harm to a beneficiary, without penalty to that beneficiary.”

The issue of harm was dealt with decisively in Appeals Committee ruling, F v Discovery Health Medical Scheme and Another (Ruling signed on 13 March 2019), attached as ANNEXURE “1”. The Appeals Committee established a two-pronged test for the applicability of Regulation 15(H)(c), in that, initial inquiry was into whether a protocol existed, second inquiry would be whether such a protocol is ineffective or causes harm or would cause harm to a beneficiary. Which is the case herein, therefore the exception envisaged in regulation 15(H)(c) should apply.

The managed care regulation 15I states that provision must be made for exceptional circumstances where drugs in the formulary have been ineffective or cause or would cause adverse reaction in a beneficiary, without penalty to that beneficiary. Medical Schemes cannot deduct from members savings as opposed to their in-hospital benefits as the diagnosis is an acute condition and a full PMB and must be funded as such.

Safeline Pharmaceuticals (Pty) Ltd was awarded the tender and contract number HP06-2021SVP for the supply and delivery of small volume parenterals and insulin devices to the Department of Health for the period of 01 MAY 2021 to 30 APRIL 2024. Cayona is a product that is being used and supplied to public hospitals and is therefore offering the best quality standard care
treatment (see attached ANNEXURE “2”).

To also take into consideration in this matter is the best interest of the child. The Scheme’s decision fails to consider the rights of the premature infants entrenched in our constitution, namely the right to access healthcare and the right to life as entrenched in the highest law of our land, the Constitution of the Republic of South Africa, 1996 (Bill of Rights), section 27 obliges the state to develop legislation to progressively realise the right of access to healthcare. The Medical Schemes Act, 131 of 1998, is one of several laws that facilitates access to healthcare. It does this by creating a framework for nondiscriminatory access to medical schemes, which provide funding for Private Health Care. Furthermore, the Scheme should consider those rights as contained in The Children’s Act, 38 of 2005, which states as follows:

“Section 9: best Interest of the Child paramount
In all matters concerning the care, protection and well-being of a child the standard that the child’s best interest is of paramount importance must be applied”

It goes without saying that to fund the product Cayona is in the best interest of the premature infants as it will avoid apnea.

The child’s best interests must be of paramount importance and sets out a broad perspective of the rights of a child to be of primary consideration. This indicates that the child’s interests are the only conclusive factor to be considered, and no other factor should be considered when deciding on matters for the child. Common law has defined the standard of the best interest of the child ‘as a golden thread which runs throughout the whole fabric of our law relating to children.

In terms of the Children’s Act, section 11. States that, Children with disability or chronic illness.

(1) In any matter concerning a child with a disability due consideration must be given to—
(a) providing the child with parental care, family care or special care as and when appropriate.
(b) making it possible for the child to participate in social, cultural, religious, and educational activities,
recognising the special needs that the child may have.
(c) providing the child with conditions that ensure dignity, promote self-reliance, and facilitate active participation in the community; and
(d) providing the child and the child’s caregiver with the necessary support services.
(2) In any matter concerning a child with chronic illness due consideration must be given to—
(a) providing the child with parental care, family care or special care as and when appropriate.
(b) providing the child with conditions that ensure dignity, promote self-reliance, and facilitate active
participation in the community; and
(c) providing the child with the necessary support services.
(3) A child with a disability or chronic illness has the right not to be subjected to medical, social, cultural, or religious practices that are detrimental to his or her health, well-being or dignity.
It is in best interests of the premature infants to receive Cayona as the appropriate treatment. It cannot be, that, withholding funding of the necessary treatment would ever amount to the best interests of the child. We therefore submit that schemes reconsider their decision to not fully fund the above mentioned product and to act in accordance with the provisions of the Medical Schemes Act, its regulations and the Children’s Act as stated above.