Important Development: New Breast Cancer Drugs Reampla (palbosiklib) and Valamor (ribosiklib) Added to the SGK Reimbursement List

Hormone-positive breast cancer treatment: the drugs we have discussed most over the last 5 years are CDK 4/6 inhibitors. These drugs inhibit the mitosis (cell division) cycle, and this group includes 3 internationally approved drugs with similar mechanisms of action: palbosiklib (Reampla), ribosiklib (Valamor) and abemasiklib. In 2015, the first drug in this group to receive approval from the US Food and Drug Administration (FDA) for patients with breast cancer was palbosiklib (Ibrance in the United States, Reampla in Turkey). Subsequently, abemasiklib (not yet reimbursed in Turkey) and ribosiklib (Kisqali in the United States, Valamor in Turkey) received FDA approval in 2017. These drugs were approved and licensed by Turkey’s Ministry of Health in 2019 for use in patients with breast cancer; however, until now they had not been included in reimbursement under the Social Security Institution’s Healthcare Implementation Communiqué (SUT).

CDK 4/6 inhibitors do not act directly on female hormones, but exert anticancer effects in hormone-positive breast cancer through the cell cycle. CDK inhibitors have brought a breath of fresh air to the treatment of hormone-positive breast cancer.

Under the Official Gazette Communiqué of May 9, 2020, it was decided that the costs of "Reampla" and "Valamor" would be covered by SGK in the following circumstances.

Palbosiklib (Reampla)

Postmenopausal patients with estrogen receptor positivity of at least 10% and Human Epidermal Growth Factor 2 (HER2) negativity, who have recurrent (relapsed) or metastatic breast cancer.

Conditions of use:

In patients who have not previously received any endocrine (hormone-suppressing) treatment for recurrent or metastatic breast cancer, or who have completed adjuvant (protective) treatment and developed recurrence/metastasis 12 months later, the cost is covered by SGK when used in combination with letrozol.

When used in combination with fulvestrant in the presence of clinical and/or radiological progression after more than 6 months of first-line aromatase inhibitor treatment for recurrent/metastatic breast cancer, SGK coverage applies. In patients who have previously received fulvestrant, whose disease recurs within the first 12 months of adjuvant aromatase inhibitor treatment, or who have received more than one line of aromatase inhibitors for metastatic disease, SGK coverage does not apply.

When used with fulvestrant in patients who develop recurrence/metastasis while continuing adjuvant aromatase inhibitor treatment (provided they have received it for at least 12 months), or within 12 months after completing it, SGK coverage applies. In patients who have previously received fulvestrant, whose disease recurs within the first 12 months of adjuvant aromatase inhibitor treatment, or who have received more than one line of aromatase inhibitors for metastatic disease, SGK coverage does not apply.

At the end of the report period, the new report issued for continuation of treatment must state that there is no disease progression.

Ribosiklib (Valamor)

Postmenopausal patients with recurrent or metastatic breast cancer, estrogen receptor positivity of at least 10% and Human Epidermal Growth Factor 2 (HER2) negativity.

Conditions of use:

The cost is covered by SGK when used in combination with letrozol in patients who have not previously received any hormonal treatment for recurrent or metastatic breast cancer, or who develop recurrence/metastasis 12 months after completing adjuvant treatment.

When used in combination with fulvestrant in the presence of clinical and/or radiological progression after more than 6 months of first-line aromatase inhibitor treatment for recurrent/metastatic breast cancer, SGK coverage applies. In patients who have previously received fulvestrant, whose disease recurs within the first 12 months of adjuvant aromatase inhibitor treatment, or who have received more than one line of aromatase inhibitors for metastatic disease, SGK coverage does not apply.

When used with fulvestrant in patients who develop recurrence/metastasis while continuing adjuvant aromatase inhibitor treatment (provided they have received it for at least 12 months), or within 12 months after completing it, SGK coverage applies. In patients who have previously received fulvestrant, whose disease recurs within the first 12 months of adjuvant aromatase inhibitor treatment, or who have received more than one line of aromatase inhibitors for metastatic disease, SGK coverage does not apply.

At the end of the report period, the new report issued for continuation of treatment must state that there is no disease progression.

A Summary of Treatments for Hormone-positive Breast Cancer

Just as organs do not have only one type of cancer, breast cancer also has many subtypes. The most common is the hormone receptor-positive, HER2 (CerbB2)-negative subtype. Hormone receptors here refer to estrogen (ER) and progesterone (PR) receptors on the surface of tumor cells. Metastatic (stage 4) breast cancer is hormone receptor-positive in 75% of patients.

The types of breast cancer according to their biological characteristics can be seen below:

When a patient presents with hormone receptor-positive, HER2-negative metastatic breast cancer, endocrine (hormonal) treatment is given first if there are no life-threatening metastases.

The drugs used in endocrine (hormonal) treatment can be considered in the following 4 classes:

1. Selective estrogen receptor modulator: tamoksifen,
2. LHRH agonists for ovarian suppression: goserelin, leuprolid (löprolid)
3. Selective estrogen downregulator: fulvestrant
4. Aromatase inhibitors: anastrozol, letrozol, eksemestan

Endocrine treatment in breast cancer began with tamoksifen in 1977 (see the discovery of tamoksifen). After 1995, LHRH agonists providing ovarian suppression (suppression of ovarian function) and aromatase inhibitors for postmenopausal patients entered treatment. Fulvestrant began to be used in treatment in 2002. For a long time, these treatments were used individually in sequence, with a switch to the next endocrine treatment when progression (cancer advancement) occurred.

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- Related topic: Hormone-positive breast cancer treatments (detailed)